<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IDAG400R4</udiDi>
    <basicUdiDi>B-IDAG400R4</basicUdiDi>
    <tradeName>Dengue NS1 Antigen Rapid Tests</tradeName>
    <deviceName>Dengue NS1 Antigen Rapid Tests</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>IVDD</legislation>
    <emdnCode>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDAG4001, IDAG4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:18:56.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFq32GX</udiDi>
    <basicUdiDi>B-ICFq32GX</basicUdiDi>
    <tradeName>COVID-19/Influenza A+B Antigen Combo Rapid Test</tradeName>
    <deviceName>COVID-19/Influenza A+B Antigen Combo Rapid Test</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>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFq325,  ICFq328</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:18:55.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICFq31GV</udiDi>
    <basicUdiDi>B-ICFq31GV</basicUdiDi>
    <tradeName>COVID-19/Influenza A+B Antigen Combo Rapid Test</tradeName>
    <deviceName>COVID-19/Influenza A+B Antigen Combo Rapid Test</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>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICFq312, ICFq318</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:18:51.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IADq00FE</udiDi>
    <basicUdiDi>B-IADq00FE</basicUdiDi>
    <tradeName>Adenovirus Antigen Rapid Test (Swab)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IADq001, IADq002, IADq008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:23.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IAD60075</udiDi>
    <basicUdiDi>B-IAD60075</basicUdiDi>
    <tradeName>Adenovirus Antigen Rapid Test (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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IAD6001, IAD6002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:23.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTRA100YZ</udiDi>
    <basicUdiDi>B-DTRA100YZ</basicUdiDi>
    <tradeName>Tramadol Rapid Test</tradeName>
    <deviceName>Tramadol Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTRA1001  DTRA1002  DTRA1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:21.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DPGB100TT</udiDi>
    <basicUdiDi>B-DPGB100TT</basicUdiDi>
    <tradeName>Pregabalin Rapid Test</tradeName>
    <deviceName>Pregabalin Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPGB1001 DPGB1002  DPGB1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:17:00.262Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DMET100VU</udiDi>
    <basicUdiDi>B-DMET100VU</basicUdiDi>
    <tradeName>Methamphetamine 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>W0102160502</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMET1001, DMET1002, DMET1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:43.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DMDP100UM</udiDi>
    <basicUdiDi>B-DMDP100UM</basicUdiDi>
    <tradeName>MDPV Rapid Test</tradeName>
    <deviceName>MDPV Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMDP1001 DMDP1002 DMDP1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:41.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DETO700XL</udiDi>
    <basicUdiDi>B-DETO700XL</basicUdiDi>
    <tradeName>Etomidate Rapid Test (Saliva)</tradeName>
    <deviceName>Etomidate Rapid Test (Saliva)</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETO7002  DETO7003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:20.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DETO100WN</udiDi>
    <basicUdiDi>B-DETO100WN</basicUdiDi>
    <tradeName>Etomidate Rapid Test</tradeName>
    <deviceName>Etomidate Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DETO1002, DETO1004, DETO1007, DETO100B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:19.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DDOA718SZ</udiDi>
    <basicUdiDi>B-DDOA718SZ</basicUdiDi>
    <tradeName>Multi-Drug Test (Saliva)</tradeName>
    <deviceName>Multi-Drug Test (Saliva)</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DDOA7205,DDOA7305, DDOA7405,DDOA7505,DDOA7605,DDOA7707,DDOA7807,DDOA7907,DDOA7a07, DDOA7b07, DDOA7b65, DDOA7c07,  etc.</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:15.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CfMCT431XV</udiDi>
    <basicUdiDi>B-CfMCT431XV</basicUdiDi>
    <tradeName>cTnI/Myoglobin/CK-MB FIA</tradeName>
    <deviceName>cTnI/Myoglobin/CK-MB FIA</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>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CfMCT4312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:13.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CfDDg0097</udiDi>
    <basicUdiDi>B-CfDDg0097</basicUdiDi>
    <tradeName>D-Dimer FIA</tradeName>
    <deviceName>D-Dimer FIA</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>IVDD</legislation>
    <emdnCode>W0103020803</emdnCode>
    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CfDDg002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:11.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CTNI400ZB</udiDi>
    <basicUdiDi>B-CTNI400ZB</basicUdiDi>
    <tradeName>Cardiac Troponin I Rapid Test Cassette (WB/S/P)</tradeName>
    <deviceName>Cardiac Troponin I Rapid Test Cassette (WB/S/P)</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>IVDD</legislation>
    <emdnCode>W0102160703</emdnCode>
    <emdnDescription>TROPONIN I/T - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CTNI4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:09.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CMCT431VF</udiDi>
    <basicUdiDi>B-CMCT431VF</basicUdiDi>
    <tradeName>Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)</tradeName>
    <deviceName>Myoglobin/CK-MB/Troponin I Rapid Test Cassette (WB/S/P)</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>IVDD</legislation>
    <emdnCode>W0102160706</emdnCode>
    <emdnDescription>MULTIPLE CARDIAC MARKERS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMCT4312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:07.865Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CCK4006L</udiDi>
    <basicUdiDi>B-CCK4006L</basicUdiDi>
    <tradeName>CK-MB Rapid Test</tradeName>
    <deviceName>CK-MB Rapid Test</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>IVDD</legislation>
    <emdnCode>W0102160701</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CCK4001, CCK4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:16:05.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YPCT400A4</udiDi>
    <basicUdiDi>B-YPCT400A4</basicUdiDi>
    <tradeName>PCT Rapid Test</tradeName>
    <deviceName>PCT Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YPCT4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T05:12:01.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YCRP40RB6</udiDi>
    <basicUdiDi>B-YCRP40RB6</basicUdiDi>
    <tradeName>CRP Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160601</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YCRP40R1 YCRP40R2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T05:12:00.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-YCAL6002P</udiDi>
    <basicUdiDi>B-YCAL6002P</basicUdiDi>
    <tradeName>Calprotectin Rapid Test</tradeName>
    <deviceName>Calprotectin Rapid Test</deviceName>
    <manufacturerName>Hangzhou Clongene Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030069</manufacturerSrn>
    <authorisedRepresentativeName>HUMISS TRADING S. L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000040177</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160699</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YCAL6001 YCAL6002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T05:11:59.450Z</lastUpdated>
  </row>
</eudamedExport>