<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936020140706</udiDi>
    <basicUdiDi>B-06936020140706</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-02-10t</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:10:20.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020140690</udiDi>
    <basicUdiDi>B-06936020140690</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-02-5t</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:10:19.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936020140683</udiDi>
    <basicUdiDi>B-06936020140683</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-02-1t</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:10:18.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935091672017</udiDi>
    <basicUdiDi>B-06935091672017</basicUdiDi>
    <tradeName>Strep A Antigen Rapid Test (Immunochromatography)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qingdao Hightop Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016890</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:39:50.870Z</lastUpdated>
  </row>
  <row>
    <udiDi>06935091671812</udiDi>
    <basicUdiDi>B-06935091671812</basicUdiDi>
    <tradeName>Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Qingdao Hightop Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016890</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090101</emdnCode>
    <emdnDescription>CHLAMYDIA AG - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T11:39:38.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>06934078018749</udiDi>
    <basicUdiDi>B-06934078018749</basicUdiDi>
    <tradeName>Ferrarihub</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>W0105090103</emdnCode>
    <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>
  </row>
  <row>
    <udiDi>06438115001034</udiDi>
    <basicUdiDi>B-06438115001034</basicUdiDi>
    <tradeName>QuikRead go Strep A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aidian Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000023611</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>135883</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:07:40.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>00628347561130</udiDi>
    <basicUdiDi>62834756AL02090279</basicUdiDi>
    <tradeName>Artron Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-322P</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T13:55:49.370Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987815008710</udiDi>
    <basicUdiDi>4987815TB019Z</basicUdiDi>
    <tradeName>Capilia TB-Neo 10T/Box</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TAUNS Laboratories, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000007041</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CATB0871</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:15:19.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958968</udiDi>
    <basicUdiDi>59026439CRTL916RB</basicUdiDi>
    <tradeName>05902643958968</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-916-2502</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:12:43.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958951</udiDi>
    <basicUdiDi>59026439CRTL916RB</basicUdiDi>
    <tradeName>05902643958951</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-916-1002</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:12:42.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958425</udiDi>
    <basicUdiDi>59026439BRT325JL</basicUdiDi>
    <tradeName>05902643958425</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-325-P020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:11:45.941Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958371</udiDi>
    <basicUdiDi>59026439BRT320JA</basicUdiDi>
    <tradeName>05902643958371</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-321-K020</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:11:38.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>05902643958166</udiDi>
    <basicUdiDi>59026439CRT308JZ</basicUdiDi>
    <tradeName>05902643958166</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000039473</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-308-P050</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-21T14:11:12.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230371</udiDi>
    <basicUdiDi>697683823P201900F9</basicUdiDi>
    <tradeName>GenSure Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>P2019C02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230388</udiDi>
    <basicUdiDi>697683823P201900F9</basicUdiDi>
    <tradeName>GenSure Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>P2019C05</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230395</udiDi>
    <basicUdiDi>697683823P201900F9</basicUdiDi>
    <tradeName>GenSure Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>P2019C10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838230401</udiDi>
    <basicUdiDi>697683823P201900F9</basicUdiDi>
    <tradeName>GenSure Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>P2019C20</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:06.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838235352</udiDi>
    <basicUdiDi>697683823P201900F9</basicUdiDi>
    <tradeName>EuroGen Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>Y2019C01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:05.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>16976838235369</udiDi>
    <basicUdiDi>697683823P201900F9</basicUdiDi>
    <tradeName>EuroGen Strep A Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</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>Y2019C02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T00:45:05.260Z</lastUpdated>
  </row>
</eudamedExport>