<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-DTHC100VZ</udiDi>
    <basicUdiDi>B-DTHC100VZ</basicUdiDi>
    <tradeName>Marijuana (THC) Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</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>DTHC1001,STHC1002,DTHC1004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:04:05.699Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOV05FD</udiDi>
    <basicUdiDi>B-ICOV05FD</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</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>ICOV5002-B001;ICOV5002-B005;ICOV5002-B025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:59:50.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IrHPG6009G</udiDi>
    <basicUdiDi>B-IrHPG6009G</basicUdiDi>
    <tradeName>H.pylori Antigen Rapid Test Cassette (Feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</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>IrHPG6002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:59:08.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISCOVu005G</udiDi>
    <basicUdiDi>B-ISCOVu005G</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:59:07.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TFOB6003V</udiDi>
    <basicUdiDi>B-TFOB6003V</basicUdiDi>
    <tradeName>Fecal Occult Blood Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</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>TFOB6002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:54:35.571Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WSHCG100WM</udiDi>
    <basicUdiDi>B-WSHCG100WM</basicUdiDi>
    <tradeName>HCG Pregnancy Rapid Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSHCG1001,WSHCG1002,WSHCG1003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:15.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WSLH100A9</udiDi>
    <basicUdiDi>B-WSLH100A9</basicUdiDi>
    <tradeName>LH Ovulation Rapid Tests</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WSLH1001,WSLH1002,WSLH1003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:52:15.470Z</lastUpdated>
  </row>
</eudamedExport>