<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06934078011177</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-P11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:58:47.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078011184</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-P11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:58:45.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078011191</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-DP11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:58:45.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078011207</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-DP11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:58:44.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078008351</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-C81N001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:57:18.442Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078099120</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-C81N002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:57:17.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078049095</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-S81P001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:57:11.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078037801</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-S81N001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:57:09.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078000362</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-S81N002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T19:57:08.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078000171</udiDi>
    <basicUdiDi>69340780HCG21A00FD</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-S21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T03:36:59.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078011139</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-C11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T03:34:36.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078011160</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-C11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-10-10T03:34:35.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078051289</udiDi>
    <basicUdiDi>69340780STA81A01WM</basicUdiDi>
    <tradeName>RightSign Home+</tradeName>
    <deviceName>Strep A Rapid Test Cassette (Throat Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-C81H001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-10-08T22:10:11.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078006104</udiDi>
    <basicUdiDi>69340780STA81A00WK</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>Strep A Rapid Test Cassette(Throat Swab); Strep A Rapid Test Strip(Throat Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-C81P001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-10-08T22:09:54.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078015007</udiDi>
    <basicUdiDi>69340780SFOB01A007P</basicUdiDi>
    <tradeName>Proline</tradeName>
    <deviceName>Proline FOB CE buffer</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104010805</emdnCode>
    <emdnDescription>BUFFERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFOB-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-08T22:09:51.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078098062</udiDi>
    <basicUdiDi>69340780HPG61A00PN</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>H.pylori Antigen Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHPG-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-08T22:09:47.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078041020</udiDi>
    <basicUdiDi>69340780HCG21A00FD</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Cassette (Serum/Plasma/Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-C21</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-08T22:09:44.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078008306</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>Ethyl Glucuronide Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160507</emdnCode>
    <emdnDescription>METHADONE INCL. EDDP - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-C11</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-10-08T22:09:27.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WVPH-P70HWB</udiDi>
    <basicUdiDi>B-WVPH-P70HWB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Bacterial Vaginosis PH Panel (Vaginal Discharge)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010699</emdnCode>
    <emdnDescription>CLIN. CHEM. RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WVPH-P70H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:15:39.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WTXM-C316Q</udiDi>
    <basicUdiDi>B-WTXM-C316Q</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Toxo IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050199</emdnCode>
    <emdnDescription>TOXOPLASMA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WTXM-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:15:34.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WTMC-C34WW</udiDi>
    <basicUdiDi>B-WTMC-C34WW</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>ToRCH (Toxo, Rubella, CMV, HSV) IgM Combo Rapid Test (Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900299</emdnCode>
    <emdnDescription>INFECTIOUS IMMUNOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WTMC-C34</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:15:19.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WTGM-MC42SH</udiDi>
    <basicUdiDi>B-WTGM-MC42SH</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Toxo IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050199</emdnCode>
    <emdnDescription>TOXOPLASMA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WTGM-MC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:15:16.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WSTB-C71Z3</udiDi>
    <basicUdiDi>B-WSTB-C71Z3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Strep B Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011101</emdnCode>
    <emdnDescription>STREPTOCOCCAL DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSTB-C71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:15:13.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WSFIT-C41VY</udiDi>
    <basicUdiDi>B-WSFIT-C41VY</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>sFlt-1 Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050212</emdnCode>
    <emdnDescription>SOLUBLE FMS-LIKE TYROSINE KINASE-1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSFIT-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:15:10.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WRUM-C314F</udiDi>
    <basicUdiDi>B-WRUM-C314F</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Rubella IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040199</emdnCode>
    <emdnDescription>RUBELLA VIRUS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRUM-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:14:55.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WRUG-C312D</udiDi>
    <basicUdiDi>B-WRUG-C312D</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Rubella IgG Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040199</emdnCode>
    <emdnDescription>RUBELLA VIRUS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WRUG-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:14:53.050Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WPAMG-C71NY</udiDi>
    <basicUdiDi>B-WPAMG-C71NY</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Placental Alpha Microglobulin 1 (PAMG-1) Rapid Test Cassette(Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050299</emdnCode>
    <emdnDescription>PREGNANCY TESTING HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WPAMG-C71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:14:50.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-ES11QK</udiDi>
    <basicUdiDi>B-WLH-ES11QK</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Strip(Urine);</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-ES11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:42.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-S11HPU</udiDi>
    <basicUdiDi>B-WLH-S11HPU</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-S11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:39.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-S115N</udiDi>
    <basicUdiDi>B-WLH-S115N</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-S11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:36.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-M114Q</udiDi>
    <basicUdiDi>B-WLH-M114Q</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-M11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:33.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-ES11HHA</udiDi>
    <basicUdiDi>B-WLH-ES11HHA</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Strip(Urine);</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-ES11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:24.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-EM11PM</udiDi>
    <basicUdiDi>B-WLH-EM11PM</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Midstream(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-EM11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:21.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-EC11N3</udiDi>
    <basicUdiDi>B-WLH-EC11N3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Cassette(Urine);</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-EC11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:18.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-EC11HDS</udiDi>
    <basicUdiDi>B-WLH-EC11HDS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Cassette(Urine);</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-EC11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:12:14.985Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-C11HLC</udiDi>
    <basicUdiDi>B-WLH-C11HLC</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-C11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:59.541Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WLH-C1136</udiDi>
    <basicUdiDi>B-WLH-C1136</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>LH Ovulation Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:56.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WIGFF-C72JV</udiDi>
    <basicUdiDi>B-WIGFF-C72JV</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>IGFBP-1 &amp; fFN Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021499</emdnCode>
    <emdnDescription>MULTIPLE IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WIGFF-C72</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:53.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WIGF-C71;WIGF-S71RR</udiDi>
    <basicUdiDi>B-WIGF-C71;WIGF-S71RR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Insulin Growth Factor Binding Protein 1(IGFBP-1) Rapid Test Cassette (Swab); Insulin Growth Factor Binding Protein 1(IGFBP-1) Rapid Test Strip (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060405</emdnCode>
    <emdnDescription>INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN 1</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WIGF-C71;WIGF-S71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:50.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHSM-C31W8</udiDi>
    <basicUdiDi>B-WHSM-C31W8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HSV 1/2 IgM Rapid Test Cassette (Serum/plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040304</emdnCode>
    <emdnDescription>HSV 1+2 IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHSM-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:27.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHPV-C72YJ</udiDi>
    <basicUdiDi>B-WHPV-C72YJ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HPV16/18 Antigen Rapid Test Cassette(Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041001</emdnCode>
    <emdnDescription>HPV ANTIGEN / ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHPV-C72</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:24.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-S11PY</udiDi>
    <basicUdiDi>B-WHCG-S11PY</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Strip(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-S11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:21.181Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-S11HEH</udiDi>
    <basicUdiDi>B-WHCG-S11HEH</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Strip(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-S11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:04.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-M11P2</udiDi>
    <basicUdiDi>B-WHCG-M11P2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Midstream(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-M11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:11:01.664Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-ES11HEX</udiDi>
    <basicUdiDi>B-WHCG-ES11HEX</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Strip(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-ES11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:58.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-ES11F8</udiDi>
    <basicUdiDi>B-WHCG-ES11F8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Strip(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-ES11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:55.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-EM11EA</udiDi>
    <basicUdiDi>B-WHCG-EM11EA</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Midstream(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EM11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:38.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-EC11HBF</udiDi>
    <basicUdiDi>B-WHCG-EC11HBF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EC11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:32.125Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-EC11CQ</udiDi>
    <basicUdiDi>B-WHCG-EC11CQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EC11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:28.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-C11MG</udiDi>
    <basicUdiDi>B-WHCG-C11MG</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:25.277Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WHCG-C11HAZ</udiDi>
    <basicUdiDi>B-WHCG-C11HAZ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HCG Pregnancy Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-C11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:10:08.106Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WGON-C71US</udiDi>
    <basicUdiDi>B-WGON-C71US</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Gonorrhea Rapid Test Cassette (Cervical/Urethral swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010201</emdnCode>
    <emdnDescription>GONOCOCCAL ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WGON-C71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:01:56.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WFSH-M11UT</udiDi>
    <basicUdiDi>B-WFSH-M11UT</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FSH Menopause Rapid Test Midstream (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160301</emdnCode>
    <emdnDescription>FSH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WFSH-M11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:01:41.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WFFN-C71QL</udiDi>
    <basicUdiDi>B-WFFN-C71QL</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Fetal Fibronectin (fFN) Rapid Test Cassette ( Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019005</emdnCode>
    <emdnDescription>FIBRONECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WFFN-C71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:01:37.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WCMM-C31R5</udiDi>
    <basicUdiDi>B-WCMM-C31R5</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CMV IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040299</emdnCode>
    <emdnDescription>CMV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WCMM-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:01:34.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WCMG-C31P3</udiDi>
    <basicUdiDi>B-WCMG-C31P3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CMV IgG Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040299</emdnCode>
    <emdnDescription>CMV REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WCMG-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T20:01:31.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WAMH-C32NE</udiDi>
    <basicUdiDi>B-WAMH-C32NE</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>AMH Semi-Quantitative Rapid Test Cassette (Serum /Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160399</emdnCode>
    <emdnDescription>FERTILITY/PREGNANCY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WAMH-C32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T19:59:40.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SVD-C4243</udiDi>
    <basicUdiDi>B-SVD-C4243</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Vitamin D Rapid Test Cassette</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SVD-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T17:09:23.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-STSH-C41YL</udiDi>
    <basicUdiDi>B-STSH-C41YL</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TSH Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020410</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STSH-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T17:09:07.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SSP-C917D</udiDi>
    <basicUdiDi>B-SSP-C917D</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>SP-10 Male Fertility Rapid Test Cassette(Semen)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050199</emdnCode>
    <emdnDescription>FERTILITY FUNCTION HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSP-C91</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T17:06:34.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SHAC-C51HA</udiDi>
    <basicUdiDi>B-SHAC-C51HA</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HbA1c Semi-quantitative Rapid Test Cassette（Whole blood）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SHAC-C51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T17:00:53.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SGP73-C317A</udiDi>
    <basicUdiDi>B-SGP73-C317A</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Golgi Protein 73(GP73) Rapid Test Cassette(Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGP73-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T17:00:31.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SEC-C61UU</udiDi>
    <basicUdiDi>B-SEC-C61UU</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>E.coli O157 Antigen Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011501</emdnCode>
    <emdnDescription>E. COLI DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEC-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:47:19.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCJ-C61WF</udiDi>
    <basicUdiDi>B-SCJ-C61WF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Campylobacter jejuni Antigen Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011401</emdnCode>
    <emdnDescription>CAMPYLOBACTER DIRECT ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCJ-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:41:28.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-SCAR-MC95D2</udiDi>
    <basicUdiDi>B-SCAR-MC95D2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CARBA-5 Rapid Test Cassette(Culture)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCAR-MC95</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:38:52.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PSAA-MC42CT</udiDi>
    <basicUdiDi>B-PSAA-MC42CT</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Serum Amyloid A Rapid Test Cassette(Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSAA-MC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:19:07.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PPCT-C43SF</udiDi>
    <basicUdiDi>B-PPCT-C43SF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PCT Semi-Quantitative Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PPCT-C43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:18:14.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PMXA-C41SQ</udiDi>
    <basicUdiDi>B-PMXA-C41SQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>MxA Rapid Test Cassette(Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMXA-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:17:50.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PMCP-MC42GE</udiDi>
    <basicUdiDi>B-PMCP-MC42GE</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>MxA/CRP Combo Rapid Test Cassette(Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMCP-MC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:17:46.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCPC-MC46CC</udiDi>
    <basicUdiDi>B-PCPC-MC46CC</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PCT+CRP Semi-quantitative Combo Rapid Test (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCPC-MC46</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:15:47.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCAP-MC639N</udiDi>
    <basicUdiDi>B-PCAP-MC639N</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Calprotectin Semi-quantitative Rapid Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCAP-MC63</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:15:13.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PCAP-MC629L</udiDi>
    <basicUdiDi>B-PCAP-MC629L</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Calprotectin Semi-quantitative Rapid Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019009</emdnCode>
    <emdnDescription>CALPROTECTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCAP-MC62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:15:10.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPSA-C42RR</udiDi>
    <basicUdiDi>B-OPSA-C42RR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PSA Rapid Test Cassette(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPSA-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:00:23.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OPSA-C41RP</udiDi>
    <basicUdiDi>B-OPSA-C41RP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PSA Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160202</emdnCode>
    <emdnDescription>PSA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPSA-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T16:00:16.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ONMP-C11T3</udiDi>
    <basicUdiDi>B-ONMP-C11T3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>NMP22 Rapid Test Cassette (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030123</emdnCode>
    <emdnDescription>NUCLEAR MATRIX PROTEIN 22</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ONMP-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:59:36.433Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OLF-C61WL</udiDi>
    <basicUdiDi>B-OLF-C61WL</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Lactoferrin Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010304</emdnCode>
    <emdnDescription>LACTOFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OLF-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:58:05.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OFTC-C62MQ</udiDi>
    <basicUdiDi>B-OFTC-C62MQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FOB/Transferrin Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160203</emdnCode>
    <emdnDescription>FECAL OCCULT BLOOD - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFTC-C62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:55:41.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OFOB-S61HCP</udiDi>
    <basicUdiDi>B-OFOB-S61HCP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FOB Rapid Test Strip(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFOB-S61H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:55:38.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OFOB-C61H97</udiDi>
    <basicUdiDi>B-OFOB-C61H97</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FOB Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFOB-C61H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:55:20.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OFE-C42TP</udiDi>
    <basicUdiDi>B-OFE-C42TP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Ferritin semi-quantitative Rapid Test Cassette(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFE-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:55:11.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OFE-C41TM</udiDi>
    <basicUdiDi>B-OFE-C41TM</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Ferritin Rapid Test Cassette(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070102</emdnCode>
    <emdnDescription>FERRITIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OFE-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:54:55.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OCEA-C41D4</udiDi>
    <basicUdiDi>B-OCEA-C41D4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CEA Rapid Test Cassette (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCEA-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:35:45.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OCA15-C42QD</udiDi>
    <basicUdiDi>B-OCA15-C42QD</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CA15-3 Rapid Test Cassette (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OCA15-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:35:17.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OBTA-C11JD</udiDi>
    <basicUdiDi>B-OBTA-C11JD</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Bladder Tumor Antigen Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030101</emdnCode>
    <emdnDescription>BLADDER TUMOUR ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OBTA-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:35:14.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-OAFP-C41HL</udiDi>
    <basicUdiDi>B-OAFP-C41HL</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>AFP Rapid Test Cassette (Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAFP-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:32:21.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NURS-T1X6D</udiDi>
    <basicUdiDi>B-NURS-T1X6D</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Urinalysis Reagent Strip (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060401</emdnCode>
    <emdnDescription>MULTIPLE ENZYMES &amp;/OR SUBSTRATES &amp;/OR ELECTROLYTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NURS-T1X</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:31:21.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NMIA-T11MT</udiDi>
    <basicUdiDi>B-NMIA-T11MT</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Semi-quantitative Micro-Albumin Test Strip(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMIA-T11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:29:28.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NMAL-C11KP</udiDi>
    <basicUdiDi>B-NMAL-C11KP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Micro-Albumin Rapid Test Cassette (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NMAL-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:29:24.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWSH6-LC46NS</udiDi>
    <basicUdiDi>B-MWSH6-LC46NS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FSH/LH/PRL/E2/Prog/Testosterone Combo Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050199</emdnCode>
    <emdnDescription>FERTILITY FUNCTION HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWSH6-LC46</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:39.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWPRL-LC412M</udiDi>
    <basicUdiDi>B-MWPRL-LC412M</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PRL Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050108</emdnCode>
    <emdnDescription>PROLACTIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWPRL-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:35.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWLH-LC41MF</udiDi>
    <basicUdiDi>B-MWLH-LC41MF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Luteinzing Hormone(LH) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050105</emdnCode>
    <emdnDescription>LUTEINISING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWLH-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:28.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWHCG-LC41KS</udiDi>
    <basicUdiDi>B-MWHCG-LC41KS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>β-HCG Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWHCG-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:18.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWFSH-LC41TH</udiDi>
    <basicUdiDi>B-MWFSH-LC41TH</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Follicle-Stimulating Hormone(FSH) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050104</emdnCode>
    <emdnDescription>FOLLICLE STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWFSH-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:11.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWE2-LC4197</udiDi>
    <basicUdiDi>B-MWE2-LC4197</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>E2 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050103</emdnCode>
    <emdnDescription>ESTRADIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWE2-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:08.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MWAMH-LC41MC</udiDi>
    <basicUdiDi>B-MWAMH-LC41MC</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>AMH Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MWAMH-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:21:01.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSVD-LC41NR</udiDi>
    <basicUdiDi>B-MSVD-LC41NR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>25-OH Vitamin D Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060309</emdnCode>
    <emdnDescription>25-HYDROXYVITAMIN D</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSVD-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:10:32.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSVB-LC41MX</udiDi>
    <basicUdiDi>B-MSVB-LC41MX</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>VataminB12(VB12) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070204</emdnCode>
    <emdnDescription>VITAMIN B12</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSVB-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:10:29.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTT4-LC41RR</udiDi>
    <basicUdiDi>B-MSTT4-LC41RR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TT4 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTT4-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:10:25.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTT3-LC41RC</udiDi>
    <basicUdiDi>B-MSTT3-LC41RC</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TT3 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTT3-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:10:22.386Z</lastUpdated>
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  <row>
    <udiDi>D-MSTST-LC415W</udiDi>
    <basicUdiDi>B-MSTST-LC415W</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Testosterone Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTST-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:10:06.032Z</lastUpdated>
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  <row>
    <udiDi>D-MSTSH-LC41YX</udiDi>
    <basicUdiDi>B-MSTSH-LC41YX</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TSH(Thyroid-stimulating hormone) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160903</emdnCode>
    <emdnDescription>THYROID-STIMULATING HORMONE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTSH-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:10:02.776Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTRAB-LC41ZQ</udiDi>
    <basicUdiDi>B-MSTRAB-LC41ZQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Anti-TSH Receptor Antibody (TRAb) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100302</emdnCode>
    <emdnDescription>TSH RECEPTOR ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTRAB-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:57.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTPO-LC412A</udiDi>
    <basicUdiDi>B-MSTPO-LC412A</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Thyroid Peroxidase (TPO) Antibodies Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100301</emdnCode>
    <emdnDescription>THYROID PEROXIDASE (INCL. MICROSOMAL) ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTPO-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:54.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTG-LC41NW</udiDi>
    <basicUdiDi>B-MSTG-LC41NW</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Thyroglobulin Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100399</emdnCode>
    <emdnDescription>THYROID-AUTO-IMMUNE DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTG-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:35.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTC-LC45MJ</udiDi>
    <basicUdiDi>B-MSTC-LC45MJ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TSH/FT4/FT3/anti-TPO/anti-TG Combo Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTC-LC45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:32.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTC-LC44MG</udiDi>
    <basicUdiDi>B-MSTC-LC44MG</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TSH/FT4/FT3/anti-TSHR Combo Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTC-LC44</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:28.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTC-LC43ME</udiDi>
    <basicUdiDi>B-MSTC-LC43ME</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>TSH/FT4/FT3 Combo Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020499</emdnCode>
    <emdnDescription>THYROID HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTC-LC43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:24.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTAU-LC42UQ</udiDi>
    <basicUdiDi>B-MSTAU-LC42UQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Tau181/Tau217 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010201</emdnCode>
    <emdnDescription>ALZHEIMER'S DISEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTAU-LC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:07.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSTAB-LC41LX</udiDi>
    <basicUdiDi>B-MSTAB-LC41LX</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Anti-Thyroid Peroxidase Antibody (Anti-TPO) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100303</emdnCode>
    <emdnDescription>THYROGLOBULIN AUTOANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSTAB-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:09:03.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSPTH-LC41X4</udiDi>
    <basicUdiDi>B-MSPTH-LC41X4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Parathyroid Hormone(PTH) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060312</emdnCode>
    <emdnDescription>PARATHYROID HORMONE INTACT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSPTH-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:08:58.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSP1NP-LC41QF</udiDi>
    <basicUdiDi>B-MSP1NP-LC41QF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Procollagen Type 1 N-Terminal Propeptide (P1NP) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060317</emdnCode>
    <emdnDescription>PROCOLLAGEN TYPE I N TERMINAL PROPEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSP1NP-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T15:08:54.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSHAC-LC51EB</udiDi>
    <basicUdiDi>B-MSHAC-LC51EB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HbA1c Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160102</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSHAC-LC51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:50:39.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSFT4-LC41HF</udiDi>
    <basicUdiDi>B-MSFT4-LC41HF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FT4 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020405</emdnCode>
    <emdnDescription>TRIIODOTHYRONINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSFT4-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:50:22.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSFT3-LC41H2</udiDi>
    <basicUdiDi>B-MSFT3-LC41H2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>FT3 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020407</emdnCode>
    <emdnDescription>THYROXINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSFT3-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:50:18.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSFEN-LC41KM</udiDi>
    <basicUdiDi>B-MSFEN-LC41KM</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Ferritin Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160102</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC) RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSFEN-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:50:15.394Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSFA-LC41D2</udiDi>
    <basicUdiDi>B-MSFA-LC41D2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Folate Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSFA-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:50:12.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSCTX-LC41VV</udiDi>
    <basicUdiDi>B-MSCTX-LC41VV</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>C-terminal Telopeptide of Type 1 Collagen(CT) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060301</emdnCode>
    <emdnDescription>CALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSCTX-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:49:53.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSBGP-LC41K5</udiDi>
    <basicUdiDi>B-MSBGP-LC41K5</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Bone Gla Protein(BGP) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102060311</emdnCode>
    <emdnDescription>OSTEOCALCINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSBGP-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:49:50.285Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MSADA-LC42AW</udiDi>
    <basicUdiDi>B-MSADA-LC42AW</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Aβ40/Aβ42 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010201</emdnCode>
    <emdnDescription>ALZHEIMER'S DISEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MSADA-LC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:49:46.880Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MPSAA-LC31HP</udiDi>
    <basicUdiDi>B-MPSAA-LC31HP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>SAA Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160199</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPSAA-LC31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:48:44.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MPROG-LC41T3</udiDi>
    <basicUdiDi>B-MPROG-LC41T3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Progesterone Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050106</emdnCode>
    <emdnDescription>PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPROG-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:48:21.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MPPCT-LC41QS</udiDi>
    <basicUdiDi>B-MPPCT-LC41QS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Procalcitonin(PCT) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPPCT-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:47:51.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MPIL6-LC41DM</udiDi>
    <basicUdiDi>B-MPIL6-LC41DM</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Interleukin-6 (IL-6)Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030609</emdnCode>
    <emdnDescription>INTERLEUKIN 6 (IL-6)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPIL6-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:47:39.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOPGG-LC43M2</udiDi>
    <basicUdiDi>B-MOPGG-LC43M2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PG I / PG II/G17 Combo Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOPGG-LC43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:45:26.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOCEA-LC419P</udiDi>
    <basicUdiDi>B-MOCEA-LC419P</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CEA Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030112</emdnCode>
    <emdnDescription>CARCINOEMBRYONIC ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCEA-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:42:37.642Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOCA199-LC41UX</udiDi>
    <basicUdiDi>B-MOCA199-LC41UX</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CA19-9 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030103</emdnCode>
    <emdnDescription>CANCER ANTIGEN 19-9</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCA199-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:42:24.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOCA153-LC41QD</udiDi>
    <basicUdiDi>B-MOCA153-LC41QD</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CA15-3 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030102</emdnCode>
    <emdnDescription>CANCER ANTIGEN 15-3</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCA153-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:42:18.295Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOCA125-LC41PL</udiDi>
    <basicUdiDi>B-MOCA125-LC41PL</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CA-125 Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102030106</emdnCode>
    <emdnDescription>CANCER ANTIGEN 125</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOCA125-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:42:14.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MOAFP-LC41F5</udiDi>
    <basicUdiDi>B-MOAFP-LC41F5</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>AFP Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102039001</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOAFP-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:42:05.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MNMG-LC41G8</udiDi>
    <basicUdiDi>B-MNMG-LC41G8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>β2-MG Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MNMG-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:41:51.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MIHPG-LC31GJ</udiDi>
    <basicUdiDi>B-MIHPG-LC31GJ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>H. pylori Antibody Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIHPG-LC31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:39:04.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MIDEN-LC42BB</udiDi>
    <basicUdiDi>B-MIDEN-LC42BB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Dengue IgG/IgM Combo Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIDEN-LC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:38:49.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MIDEG-LC418E</udiDi>
    <basicUdiDi>B-MIDEG-LC418E</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Dengue NS1 Ag Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIDEG-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:38:46.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCTNI-LC41K7</udiDi>
    <basicUdiDi>B-MCTNI-LC41K7</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Cardiac Troponin I(cTnI) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCTNI-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:21:45.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCMYO-LC41PB</udiDi>
    <basicUdiDi>B-MCMYO-LC41PB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Myoglobin(Myo) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCMYO-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:21:33.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCMIC-LC45A7</udiDi>
    <basicUdiDi>B-MCMIC-LC45A7</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Cardiac Troponin I/CK-MB/Myoglobin/D-Dimer/NT-proBNP Combo Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCMIC-LC45</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:21:26.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCMIC-LC43A3</udiDi>
    <basicUdiDi>B-MCMIC-LC43A3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>cTnI/Myo/CK-MB Combo Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCMIC-LC43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:21:19.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCKMB-LC41AG</udiDi>
    <basicUdiDi>B-MCKMB-LC41AG</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Creatine Kinase MB(CK-MB) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCKMB-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:21:09.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCHSTN-LC41S6</udiDi>
    <basicUdiDi>B-MCHSTN-LC41S6</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I (hs-cTnI) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCHSTN-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:21:01.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCDIM-LC418N</udiDi>
    <basicUdiDi>B-MCDIM-LC418N</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>D-Dimer Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCDIM-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:20:44.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCCRP-LC41E3</udiDi>
    <basicUdiDi>B-MCCRP-LC41E3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Total C reactive protein(hsCRP +CRP) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCCRP-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:20:41.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCCPC-LC427S</udiDi>
    <basicUdiDi>B-MCCPC-LC427S</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>PCT/CRP Combo Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCCPC-LC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:20:33.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MCBNP-LC41BC</udiDi>
    <basicUdiDi>B-MCBNP-LC41BC</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>N-terminal-pro-B-type natriuretic peptide(NT-proBNP) Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCBNP-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:20:21.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MARF-LC41AR</udiDi>
    <basicUdiDi>B-MARF-LC41AR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Rheumatoid Factor (RF) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MARF-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:16:41.353Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAIGE-LC415V</udiDi>
    <basicUdiDi>B-MAIGE-LC415V</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Total IgE Quantitative Rapid Test (Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAIGE-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:15:17.527Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MACCP-LC414N</udiDi>
    <basicUdiDi>B-MACCP-LC414N</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Anti-Cyclic Citrullinated Peptide Antibody(Anti-CCP) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021112</emdnCode>
    <emdnDescription>ANTI-CYCLIC CITRULLINATED PEPTIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MACCP-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:12:32.459Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MADNA-LC414Z</udiDi>
    <basicUdiDi>B-MADNA-LC414Z</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102100105</emdnCode>
    <emdnDescription>DS DNA - ANTIBODIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MADNA-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:12:30.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MAANA-LC4138</udiDi>
    <basicUdiDi>B-MAANA-LC4138</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Antinuclear Antibody(ANA) Quantitative Rapid Test(Microfluidic Fluorescent Immunoassay)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100101</emdnCode>
    <emdnDescription>ANA SCREENING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAANA-LC41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T14:12:25.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IZGM-C42SR</udiDi>
    <basicUdiDi>B-IZGM-C42SR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>ZIKA IgG/IgM Rapid Test Cassette（Whole Blood/Serum/Plasma）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040630</emdnCode>
    <emdnDescription>ZIKA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IZGM-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:09:42.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IYFG-C41PP</udiDi>
    <basicUdiDi>B-IYFG-C41PP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Yellow Fever Virus NS1 Ag Rapid Test Cassette(Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IYFG-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:09:38.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IYFC-MC43EV</udiDi>
    <basicUdiDi>B-IYFC-MC43EV</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Yellow Fever Virus NS1 Ag and Ab Combo Rapid Test Cassette(Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IYFC-MC43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:09:17.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IYFB-MC42EE</udiDi>
    <basicUdiDi>B-IYFB-MC42EE</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Yellow Fever Virus IgG/IgM Combo Rapid Test Cassette(Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IYFB-MC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:09:15.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVZV-C413G</udiDi>
    <basicUdiDi>B-IVZV-C413G</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Varicella Zoster Virus IgM Rapid Test Cassette (Whole Blood /Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040903</emdnCode>
    <emdnDescription>VARICELLA ZOSTER VIRUS IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVZV-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:09:12.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IVC-MC62KB</udiDi>
    <basicUdiDi>B-IVC-MC62KB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>V. cholerae O1/O139 Ag Combo Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IVC-MC62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:07:24.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITYP-C61Y2</udiDi>
    <basicUdiDi>B-ITYP-C61Y2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Salmonella Typhi Antigen Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011001</emdnCode>
    <emdnDescription>SALMONELLA ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITYP-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:07:17.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITYP-C42XW</udiDi>
    <basicUdiDi>B-ITYP-C42XW</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Typhoid Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITYP-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:07:14.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITYP-C32XT</udiDi>
    <basicUdiDi>B-ITYP-C32XT</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Typhoid Rapid Test Cassette( Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011002</emdnCode>
    <emdnDescription>SALMONELLA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITYP-C32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T11:06:57.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITET-C41R4</udiDi>
    <basicUdiDi>B-ITET-C41R4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Tetanus Antibody Rapid Test Cassette(Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011709</emdnCode>
    <emdnDescription>TETANUS (CLOSTRIDIUM T.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITET-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T10:05:56.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITB-C41V4</udiDi>
    <basicUdiDi>B-ITB-C41V4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Tuberculosis Rapid Test Cassette(Whole blood /Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITB-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T10:05:31.022Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITB-C31UZ</udiDi>
    <basicUdiDi>B-ITB-C31UZ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Tuberculosis Rapid Test Cassette(Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITB-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T10:05:28.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISP-C11Z8</udiDi>
    <basicUdiDi>B-ISP-C11Z8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Streptococcus Pneumoniae Antigen Rapid Test Cassette(Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISP-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T10:01:43.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRSVA-C81RC</udiDi>
    <basicUdiDi>B-IRSVA-C81RC</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>RSV Antigen Rapid Test Cassette (Swab/Nasal Aspirate)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRSVA-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:56:18.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRSV-C81WS</udiDi>
    <basicUdiDi>B-IRSV-C81WS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>RSV Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRSV-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:56:12.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IROT-C61UA</udiDi>
    <basicUdiDi>B-IROT-C61UA</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Rotavirus Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IROT-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:54:48.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRCFN-MC84ET</udiDi>
    <basicUdiDi>B-IRCFN-MC84ET</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRCFN-MC84</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:52:33.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRCF-MC84SA8</udiDi>
    <basicUdiDi>B-IRCF-MC84SA8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRCF-MC84S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:52:30.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRCF-MC84AS</udiDi>
    <basicUdiDi>B-IRCF-MC84AS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRCF-MC84</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:52:27.141Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRAC-C62GT</udiDi>
    <basicUdiDi>B-IRAC-C62GT</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Rotavirus/Adenovirus Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRAC-C62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:52:23.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IPTG-C41QL</udiDi>
    <basicUdiDi>B-IPTG-C41QL</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Pertussis IgG Antibody Rapid Test Cassette(Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011707</emdnCode>
    <emdnDescription>BORDETELLA PERTUSSIS / PARAPERTUSSIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPTG-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:51:53.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INRV-C61U3</udiDi>
    <basicUdiDi>B-INRV-C61U3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Norovirus Antigen Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040616</emdnCode>
    <emdnDescription>NOROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INRV-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:51:44.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INGM-MC42CV</udiDi>
    <basicUdiDi>B-INGM-MC42CV</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 IgG/IgM Rapid Test Cassette（Whole Blood/ Plasma/Serum）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090502</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIBODY (AB) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INGM-MC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:51:18.973Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-INCP-C81L4</udiDi>
    <basicUdiDi>B-INCP-C81L4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Cassette（Nasal Swab/Nasopharyngeal Swab）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INCP-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:50:53.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPV-C52SP</udiDi>
    <basicUdiDi>B-IMPV-C52SP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test Cassette(Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-C52</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:49:18.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPV-C52SJB</udiDi>
    <basicUdiDi>B-IMPV-C52SJB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria P.f./P.v. Rapid Test Cassette(Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPV-C52S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:49:14.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPN-C52SF3</udiDi>
    <basicUdiDi>B-IMPN-C52SF3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test Cassette(Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPN-C52S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:48:47.877Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPN-C52PX</udiDi>
    <basicUdiDi>B-IMPN-C52PX</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria P.f./Pan Rapid Test Cassette(Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPN-C52</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:48:46.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPF-C51M5</udiDi>
    <basicUdiDi>B-IMPF-C51M5</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria p.f. Rapid test Cassette (Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPF-C51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:48:11.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMPF-C51SBQ</udiDi>
    <basicUdiDi>B-IMPF-C51SBQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria p.f. Rapid test Cassette (Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPF-C51S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:48:00.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMP-C81XF</udiDi>
    <basicUdiDi>B-IMP-C81XF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen Rapid Test Cassette(Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:47:34.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMP-C41X3</udiDi>
    <basicUdiDi>B-IMP-C41X3</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Mycoplasma Pneumoniae IgM Rapid test(Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010802</emdnCode>
    <emdnDescription>MYCOPLASMA ANTIBODY ASSAYS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMP-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:47:27.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMON-C41PD</udiDi>
    <basicUdiDi>B-IMON-C41PD</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Mononucleosis Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099003</emdnCode>
    <emdnDescription>MONONUCLEOSIS (EBV) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMON-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:47:10.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMBD-C47F2</udiDi>
    <basicUdiDi>B-IMBD-C47F2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Dengue NS1+Dengue IgG/IgM+Zika Virus IgG/IgM+Chikungunya IgG/IgM Combo Rapid Test (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMBD-C47</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:46:44.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IMAL-C53H8</udiDi>
    <basicUdiDi>B-IMAL-C53H8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Malaria PF/PV/PAN Rapid Test Cassette(Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMAL-C53</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:46:31.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILP-C11WD</udiDi>
    <basicUdiDi>B-ILP-C11WD</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Legionella Pneumophila Antigen Rapid Test Cassette (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILP-C11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:46:07.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IJEV-MC42D4</udiDi>
    <basicUdiDi>B-IJEV-MC42D4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>JEV IgG/IgM Rapid Test Cassette (Whole Blood /Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IJEV-MC42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:45:36.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHPIV-C81KR</udiDi>
    <basicUdiDi>B-IHPIV-C81KR</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HPIVs Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHPIV-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:44:44.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHPC-MC329X</udiDi>
    <basicUdiDi>B-IHPC-MC329X</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>H. pylori Antibody IgG/IgM Ab Rapid Test Cassette(Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHPC-MC32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:44:41.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHPB-S41KH</udiDi>
    <basicUdiDi>B-IHPB-S41KH</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHPB-S41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:42:35.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHMV-C81P2</udiDi>
    <basicUdiDi>B-IHMV-C81P2</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Human metapneumovirus Antigen Rapid Test Cassette(Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040617</emdnCode>
    <emdnDescription>HUMAN METAPNEUMOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHMV-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:41:51.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHAV-C41HS</udiDi>
    <basicUdiDi>B-IHAV-C41HS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HAV IgM Rapid Test Cassette (Whole blood/Serum /Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHAV-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:41:16.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHAV-C31HP</udiDi>
    <basicUdiDi>B-IHAV-C31HP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HAV IgM Rapid Test Cassette( Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHAV-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:41:14.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHAGM-C327G</udiDi>
    <basicUdiDi>B-IHAGM-C327G</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>HAV IgG/IgM Rapid Test Cassette ( Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHAGM-C32</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:40:49.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGL-C61TF</udiDi>
    <basicUdiDi>B-IGL-C61TF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Giardia Lamblia Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050208</emdnCode>
    <emdnDescription>GIARDIA LAMBLIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGL-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:39:53.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGEC-C63CN</udiDi>
    <basicUdiDi>B-IGEC-C63CN</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Giardia Lamblia+Entamoeba Histolytica+Cryptosporidium Antigen Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGEC-C63</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:39:39.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGCC-C62BS</udiDi>
    <basicUdiDi>B-IGCC-C62BS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Giardia Lamblia+Cryptosporidium Antigen Combo Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050299</emdnCode>
    <emdnDescription>PARASITOLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGCC-C62</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:39:13.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFRA-MC849L</udiDi>
    <basicUdiDi>B-IFRA-MC849L</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Influenza A&amp;B+RSV+Adenovirus Combo Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFRA-MC84</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:39:07.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLU-S82PS</udiDi>
    <basicUdiDi>B-IFLU-S82PS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Influenza A+B Rapid Test Strip (Swab/Nasal aspirate)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLU-S82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:38:48.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLU-C82MA</udiDi>
    <basicUdiDi>B-IFLU-C82MA</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Influenza A+B Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLU-C82</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:38:46.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IEV71-C41ZE</udiDi>
    <basicUdiDi>B-IEV71-C41ZE</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>EV71 IgM Rapid Test Cassette (Whole Blood /Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040602</emdnCode>
    <emdnDescription>ENTEROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IEV71-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:37:31.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IEBA-C619K</udiDi>
    <basicUdiDi>B-IEBA-C619K</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Entamoeba histolytica Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050201</emdnCode>
    <emdnDescription>ENTAMOEBA HISTOLYTICA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IEBA-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:35:49.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICPT-C61LQ</udiDi>
    <basicUdiDi>B-ICPT-C61LQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Cryptosporidium Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105050207</emdnCode>
    <emdnDescription>CRYPTOSPORIDIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICPT-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:32:36.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOVN-C81JS</udiDi>
    <basicUdiDi>B-ICOVN-C81JS</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Cassette(Nasal Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICOVN-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:32:32.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOVN-C81HGF</udiDi>
    <basicUdiDi>B-ICOVN-C81HGF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Cassette(Nasal Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090501</emdnCode>
    <emdnDescription>CORONAVIRUS ANTIGEN (AG) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICOVN-C81H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:32:26.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICKG-C42E4</udiDi>
    <basicUdiDi>B-ICKG-C42E4</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Chikungunya IgG/IgM Combo Rapid Test cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040625</emdnCode>
    <emdnDescription>CHIKUNGUNYA VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICKG-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:31:56.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICGT-C63H7</udiDi>
    <basicUdiDi>B-ICGT-C63H7</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Clostridium Difficile GDH+Toxin A+B Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICGT-C63</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:30:43.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFRAN-MC85AZ</udiDi>
    <basicUdiDi>B-ICFRAN-MC85AZ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 + Flu A&amp;B + RSV+ Adenovirus Antigen Combo Rapid Test Cassette (Nasal Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFRAN-MC85</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:30:40.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFRAM-MC86AN</udiDi>
    <basicUdiDi>B-ICFRAM-MC86AN</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19/FLU A+B/RSV/ADV/MP Antigen Combo Rapid Test Cassette (Nasopharyngeal Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFRAM-MC86</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:30:36.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFRA-MC856Y</udiDi>
    <basicUdiDi>B-ICFRA-MC856Y</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 + Flu A&amp;B+ RSV+Adenovirus Antigen Combo Rapid Test Cassette(Nasopharyngeal Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFRA-MC85</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:30:18.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFR-MC848C</udiDi>
    <basicUdiDi>B-ICFR-MC848C</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19+Flu A&amp;B+RSV Antigen Combo Rapid Test Cassette（Nasopharyngeal Swab）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090699</emdnCode>
    <emdnDescription>OTHER MULTIPLE PATHOGENS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFR-MC84</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:30:12.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFGN-MC836A</udiDi>
    <basicUdiDi>B-ICFGN-MC836A</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19 + Flu A&amp;B Antigen Combo Rapid Test Cassette (Nasal Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFGN-MC83</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:30:07.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICBAD-MC83UK</udiDi>
    <basicUdiDi>B-ICBAD-MC83UK</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>COVID-19/Flu A&amp;B Antigen Rapid Test Cassette（Swab）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090601</emdnCode>
    <emdnDescription>CORONAVIRUS / INFLUENZA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICBAD-MC83</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:29:03.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICAG-C71A9</udiDi>
    <basicUdiDi>B-ICAG-C71A9</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Candida Albicans Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060302</emdnCode>
    <emdnDescription>CANDIDA ALBICANS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICAG-C71</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:28:44.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IAST-C61LV</udiDi>
    <basicUdiDi>B-IAST-C61LV</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Astrovirus Antigen Rapid Test Cassette(Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040629</emdnCode>
    <emdnDescription>ASTROVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAST-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:28:07.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IARAN-MC658Q</udiDi>
    <basicUdiDi>B-IARAN-MC658Q</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Astrovirus+Rotavirus+Adenovirus+Norovirus Antigen Combo Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040699</emdnCode>
    <emdnDescription>VIRAL ANTIGEN/ANTIBODY DETECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IARAN-MC65</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:27:19.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IADE-C819T</udiDi>
    <basicUdiDi>B-IADE-C819T</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Adenovirus Antigen Rapid Test Cassette (Swab)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IADE-C81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:27:16.600Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IADE-C619M</udiDi>
    <basicUdiDi>B-IADE-C619M</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Adenovirus Rapid Test Cassette (Feces)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040601</emdnCode>
    <emdnDescription>ADENOVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IADE-C61</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-07T09:26:57.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CTNI-C41ME</udiDi>
    <basicUdiDi>B-CTNI-C41ME</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Cardiac Troponin I Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTNI-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T22:50:12.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMYO-C41Q8</udiDi>
    <basicUdiDi>B-CMYO-C41Q8</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160702</emdnCode>
    <emdnDescription>MYOGLOBIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMYO-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:42:25.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMIC-C43DQ</udiDi>
    <basicUdiDi>B-CMIC-C43DQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Comb Rapid Test Cassette(Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMIC-C43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:41:05.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CKMB-C41DT</udiDi>
    <basicUdiDi>B-CKMB-C41DT</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CK-MB Rapid Test Cassette（Whole blood /Serum/ Plasma）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CKMB-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:38:53.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CDIM-C41C9</udiDi>
    <basicUdiDi>B-CDIM-C41C9</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>D-Dimer Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDIM-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:16:47.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CCRP-C53GM</udiDi>
    <basicUdiDi>B-CCRP-C53GM</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CRP Semi-Quantitative Rapid Test Cassette (Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCRP-C53</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:15:59.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CCRP-C42GG</udiDi>
    <basicUdiDi>B-CCRP-C42GG</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>CRP Semi-Quantitative Rapid Test Cassette (Whole Blood/ Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCRP-C42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:15:56.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CBNP-C41E9</udiDi>
    <basicUdiDi>B-CBNP-C41E9</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>NT-proBNP Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160704</emdnCode>
    <emdnDescription>BNP / PROBNP - RT &amp; POC (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBNP-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T21:12:02.990Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ARF-C31RB</udiDi>
    <basicUdiDi>B-ARF-C31RB</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Rheumatoid Factor Rapid Test Cassette(Serum/ Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021110</emdnCode>
    <emdnDescription>RHEUMATOID FACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARF-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T20:08:49.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AMCD-C43AF</udiDi>
    <basicUdiDi>B-AMCD-C43AF</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>House Dust Mites/Cat Dander/Dog Dander Allergen IgE Combo Rapid Test Cassette(Whole blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020204</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - MONOTEST/PLURIRESULT-MULTI AG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMCD-C43</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T20:06:48.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AIGE-C41A6</udiDi>
    <basicUdiDi>B-AIGE-C41A6</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Total IgE Rapid Test Cassette (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIGE-C41</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T20:05:23.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AGLU-C51GQ</udiDi>
    <basicUdiDi>B-AGLU-C51GQ</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Celiac Rapid Test Cassette(Whole Blood)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102100699</emdnCode>
    <emdnDescription>CELIAC DISEASE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AGLU-C51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T20:04:51.921Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-AG6PD-C51UE</udiDi>
    <basicUdiDi>B-AG6PD-C51UE</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>G6PD Test Cassette（Whole blood）</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010199</emdnCode>
    <emdnDescription>ENZYMES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AG6PD-C51</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-10-06T20:04:48.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078011122</udiDi>
    <basicUdiDi>69340780ETG11A00NA</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160507</emdnCode>
    <emdnDescription>METHADONE INCL. EDDP - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-S11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-30T19:45:56.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078007354</udiDi>
    <basicUdiDi>B-06934078007354</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-C11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-30T19:45:28.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078071508</udiDi>
    <basicUdiDi>B-06934078071508</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETG-C11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-30T19:45:04.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078071386</udiDi>
    <basicUdiDi>B-06934078071386</basicUdiDi>
    <tradeName>slovakiapharm</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Midstream (Urine)(CE0123)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EM11</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-09-28T01:08:58.334Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078070785</udiDi>
    <basicUdiDi>B-06934078070785</basicUdiDi>
    <tradeName>PLUS LEKAREN</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Strip (Urine) (Self-Testing)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-ES11H</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-09-28T01:08:51.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078060113</udiDi>
    <basicUdiDi>B-06934078060113</basicUdiDi>
    <tradeName>Toto Pharma</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Midstream (Urine)(CE0123)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EM11</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-09-28T01:08:47.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078050411</udiDi>
    <basicUdiDi>B-06934078050411</basicUdiDi>
    <tradeName>PLUS LEKAREN</tradeName>
    <deviceName>hCG Pregnancy Rapid Test Midstream (Urine)(CE0123)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EM11</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-09-28T01:08:40.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078025013</udiDi>
    <basicUdiDi>B-06934078025013</basicUdiDi>
    <tradeName>Diagpal</tradeName>
    <deviceName>Lateral Flow Reader</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02079099</emdnCode>
    <emdnDescription>VARIOUS GENERAL PURPOSE IVD INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RDP-700</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-09-28T01:08:29.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078026263</udiDi>
    <basicUdiDi>69340780CHL71A00JT</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>Chlamydia Rapid Test Cassette (Swab/Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090101</emdnCode>
    <emdnDescription>CHLAMYDIA AG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WCHL-C71P001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-24T10:03:10.161Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078031939</udiDi>
    <basicUdiDi>69340780CHL71A00JT</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090101</emdnCode>
    <emdnDescription>CHLAMYDIA AG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WCHL-C71P002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-23T20:13:49.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICTG-C41HP</udiDi>
    <basicUdiDi>B-ICTG-C41HP</basicUdiDi>
    <tradeName>Rightsign</tradeName>
    <deviceName>Cryptococcus Antigen Rapid Test Cassette(Whole Blood/Serum/Plasma )</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105060303</emdnCode>
    <emdnDescription>CRYPTOCOCCUS</emdnDescription>
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    <deviceName>hCG Pregnancy Rapid Test Strip (Urine)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-ES11H</reference>
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    <lastUpdated>2026-07-16T15:26:18.788Z</lastUpdated>
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    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
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    <emdnDescription>HIV 1 / 2 - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-13T22:09:34.805Z</lastUpdated>
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    <deviceName>HBsAg Rapid Test Cassette(Serum/Plasma)</deviceName>
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    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:34.069Z</lastUpdated>
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    <deviceName>Multi-drug Rapid Test Cassette(SalivaTracer)</deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMDR-MSC8X</reference>
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    <lastUpdated>2026-07-13T14:10:25.506Z</lastUpdated>
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    <basicUdiDi>B-06934078018749</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTA-RC81</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:39.927Z</lastUpdated>
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    <udiDi>06934078008528</udiDi>
    <basicUdiDi>B-06934078008528</basicUdiDi>
    <tradeName>TRIGNOSTICS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160302</emdnCode>
    <emdnDescription>HCG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WHCG-EM11</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:38.713Z</lastUpdated>
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    <udiDi>06934078008511</udiDi>
    <basicUdiDi>B-06934078008511</basicUdiDi>
    <tradeName>TRIGNOSTICS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HangZhou Biotest  Biotech Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008191</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102160304</emdnCode>
    <emdnDescription>LH - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WLH-ES11H</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T08:22:37.517Z</lastUpdated>
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</eudamedExport>