<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>20608337000560</udiDi>
    <basicUdiDi>B-20608337000560</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, 25 Count</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001-0270</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:06:15.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1001-0371C2</udiDi>
    <basicUdiDi>B-1001-0371C2</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1001-0371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:49:07.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-1001-0370BY</udiDi>
    <basicUdiDi>B-1001-0370BY</basicUdiDi>
    <tradeName>OraQuick HCV Rapid Antibody Test</tradeName>
    <deviceName>OraQuick HCV Rapid Antibody Test, 25 Count, Korea</deviceName>
    <manufacturerName>OraSure Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009941</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1001-0370</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:49:06.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir01233BA</udiDi>
    <basicUdiDi>B-697994388Ir01233BA</basicUdiDi>
    <tradeName>D-697994388Ir01233BA</tradeName>
    <deviceName>Hepatitis E Virus IgM Antibody Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:16.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697994388Ir00434BF</udiDi>
    <basicUdiDi>B-697994388Ir00434BF</basicUdiDi>
    <tradeName>D-697994388Ir00434BF</tradeName>
    <deviceName>Hepatitis A Virus IgM Antibody Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:14.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>69743840310016</udiDi>
    <basicUdiDi>B-69743840310016</basicUdiDi>
    <tradeName>Hepatitis A IgM Rapid Test</tradeName>
    <deviceName>Hepatitis A IgM Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:13.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HAV004GYWG</udiDi>
    <basicUdiDi>B-697424646HAV004GYWG</basicUdiDi>
    <tradeName>Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:49.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HAV003GWW7</udiDi>
    <basicUdiDi>B-697424646HAV003GWW7</basicUdiDi>
    <tradeName>Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Hepatitis A Virus(HAV) IgM Rapid Test (Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:48.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HAV002GUVW</udiDi>
    <basicUdiDi>B-697424646HAV002GUVW</basicUdiDi>
    <tradeName>Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hepatitis A Virus(HAV) IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:47.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HAV001GSVM</udiDi>
    <basicUdiDi>B-697424646HAV001GSVM</basicUdiDi>
    <tradeName>Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hepatitis A Virus(HAV) IgM Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:42.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-697424646HAV000GQVC</udiDi>
    <basicUdiDi>B-697424646HAV000GQVC</basicUdiDi>
    <tradeName>Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Hepatitis A Virus Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-4012/HAV-4022/HAV-3012/HAV-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:41.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182723972</udiDi>
    <basicUdiDi>B-62230182723972</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>HAV IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>D-788 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:37.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041043500</udiDi>
    <basicUdiDi>B-62230041043500</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Cassette (Serum/Plasma)</tradeName>
    <deviceName>HAV IgM Rapid Test Cassette (Serum/Plasma)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1192 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:30:35.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974785750600</udiDi>
    <basicUdiDi>B-06974785750600</basicUdiDi>
    <tradeName>HEV IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>HEV IgG/IgM Rapid Test (Serum/Plasma)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHE-6013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:57.214Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-nvm-622970N-304Z</udiDi>
    <basicUdiDi>B-nvm-622970N-304Z</basicUdiDi>
    <tradeName>NADAL® HAV IgG/IgM Test</tradeName>
    <deviceName>HAV IgG/IgM Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>622970N-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:29:17.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIHEVb-422YB</udiDi>
    <basicUdiDi>B-VIHEVb-422YB</basicUdiDi>
    <tradeName>HEV IgG/IgM Rapid Test</tradeName>
    <deviceName>HEV IgG/IgM Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIHEVb-422</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:44.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-VIHE-402LJ</udiDi>
    <basicUdiDi>B-VIHE-402LJ</basicUdiDi>
    <tradeName>HEV IgM Rapid Test</tradeName>
    <deviceName>HEV IgM Rapid Test</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VIHE-402</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:23:40.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHCV-C31JH</udiDi>
    <basicUdiDi>B-IHCV-C31JH</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>HCV 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 A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090202</emdnCode>
    <emdnDescription>HCV ANTIBODY -RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHCV-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:34.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHBSG-C31AR</udiDi>
    <basicUdiDi>B-IHBSG-C31AR</basicUdiDi>
    <tradeName>RightSign</tradeName>
    <deviceName>HBsAg 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 A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090201</emdnCode>
    <emdnDescription>HBSAG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHBSG-C31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:34.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HAV-D02aCP</udiDi>
    <basicUdiDi>B-HAV-D02aCP</basicUdiDi>
    <tradeName>Hepatitis A Virus Antibody Rapid Test</tradeName>
    <deviceName>Hepatitis A Virus Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090299</emdnCode>
    <emdnDescription>HEPATITIS VIRUSES - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HAV-D02a</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:52:08.537Z</lastUpdated>
  </row>
</eudamedExport>