<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-ICOVu00A4</udiDi>
    <basicUdiDi>B-ICOVu00A4</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test Cassette (Nasal Swab)</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Cassette (Nasal Swab)</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>ICOVu002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:20.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOV700Z9</udiDi>
    <basicUdiDi>B-ICOV700Z9</basicUdiDi>
    <tradeName>COVID-19 Antigen Rapid Test Cassette (Saliva)</tradeName>
    <deviceName>COVID-19 Antigen Rapid Test Cassette (Saliva)</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>ICOV7002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:19.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOV52N32</udiDi>
    <basicUdiDi>B-ICOV52N32</basicUdiDi>
    <tradeName>SARS-CoV-2 Nucleic Acid RT-PCR Test Kit</tradeName>
    <deviceName>SARS-CoV-2 Nucleic Acid RT-PCR Test Kit</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>W0105040599</emdnCode>
    <emdnDescription>VIROLOGY - NA REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICOV52Nb, ICOV52Na</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:15.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOV421Z2</udiDi>
    <basicUdiDi>B-ICOV421Z2</basicUdiDi>
    <tradeName>COVID-19 IgG/IgM Rapid Test</tradeName>
    <deviceName>COVID-19 IgG/IgM 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>ICOV4212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:14.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICOV400YS</udiDi>
    <basicUdiDi>B-ICOV400YS</basicUdiDi>
    <tradeName>COVID-19 Neutralization Antibody Rapid Test Cassette (WB/S/P)</tradeName>
    <deviceName>COVID-19 Neutralization Antibody 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICNA4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:13.797Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ICHI421TS</udiDi>
    <basicUdiDi>B-ICHI421TS</basicUdiDi>
    <tradeName>Chikungunya IgG/IgM Rapid Test</tradeName>
    <deviceName>Chikungunya IgG/IgM 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>ICHI4212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:13.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IBRU421ZF</udiDi>
    <basicUdiDi>B-IBRU421ZF</basicUdiDi>
    <tradeName>Brucellosis IgG/IgM Rapid Test</tradeName>
    <deviceName>Brucellosis IgG/IgM 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBRU4211, IBRU4212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:08.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DKT100B9</udiDi>
    <basicUdiDi>B-DKT100B9</basicUdiDi>
    <tradeName>Synthetic Marijuana (K2) Rapid Tests</tradeName>
    <deviceName>Synthetic Marijuana (K2) 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DKT1001, DKT1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:08.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CfNT40094</udiDi>
    <basicUdiDi>B-CfNT40094</basicUdiDi>
    <tradeName>NT-proBNP FIA</tradeName>
    <deviceName>NT-proBNP 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>W0102160799</emdnCode>
    <emdnDescription>CARDIAC MARKERS - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CfNT4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-08T19:50:07.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DOPI100Y2</udiDi>
    <basicUdiDi>B-DOPI100Y2</basicUdiDi>
    <tradeName>Opiates Rapid Test</tradeName>
    <deviceName>Opiates 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>W0102160508</emdnCode>
    <emdnDescription>OPIATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOPI1001, DOPI1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T23:05:24.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOT700W6</udiDi>
    <basicUdiDi>B-DCOT700W6</basicUdiDi>
    <tradeName>Cotinine Rapid Test (Saliva)</tradeName>
    <deviceName>Cotinine Rapid Test (Saliva)</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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOT7001, DCOT7002, DCOT7004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T23:05:23.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DTCA100TU</udiDi>
    <basicUdiDi>B-DTCA100TU</basicUdiDi>
    <tradeName>Tricyclic Antidepressants (TCA) Rapid Test</tradeName>
    <deviceName>Tricyclic Antidepressants (TCA) 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>W0102160510</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DTCA1001, DTCA1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:46.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DPCP100VH</udiDi>
    <basicUdiDi>B-DPCP100VH</basicUdiDi>
    <tradeName>Phencyclidine Rapid Test</tradeName>
    <deviceName>Phencyclidine 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>W0102160509</emdnCode>
    <emdnDescription>PHENCYCLIDINE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPCP1001, DPCP1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:44.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DMTD100XH</udiDi>
    <basicUdiDi>B-DMTD100XH</basicUdiDi>
    <tradeName>Methadone Rapid Test</tradeName>
    <deviceName>Methadone 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>W0102160507</emdnCode>
    <emdnDescription>METHADONE INCL. EDDP - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMTD1001, DMTD1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:40.995Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DMDM100TY</udiDi>
    <basicUdiDi>B-DMDM100TY</basicUdiDi>
    <tradeName>MDMA (Ecstasy) Rapid Test</tradeName>
    <deviceName>MDMA (Ecstasy) 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>W0102160502</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMDM1001, DMDM1002, DMDM1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:40.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOT100V8</udiDi>
    <basicUdiDi>B-DCOT100V8</basicUdiDi>
    <tradeName>Cotinine Rapid Test</tradeName>
    <deviceName>Cotinine 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>W0102160599</emdnCode>
    <emdnDescription>DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOT1001, DCOT1002, DCOT1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:39.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DCOC100RH</udiDi>
    <basicUdiDi>B-DCOC100RH</basicUdiDi>
    <tradeName>Cocaine Rapid Test</tradeName>
    <deviceName>Cocaine 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>W0102160506</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCOC1001, DCOC1002, DCOC1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:38.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBZO100XH</udiDi>
    <basicUdiDi>B-DBZO100XH</basicUdiDi>
    <tradeName>Benzodiazepines Rapid Test</tradeName>
    <deviceName>Benzodiazepines 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>W0102160504</emdnCode>
    <emdnDescription>BENZODIAZEPINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBZO7001, DBZO7002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:34.751Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DBAR100PK</udiDi>
    <basicUdiDi>B-DBAR100PK</basicUdiDi>
    <tradeName>Barbiturates Rapid Test</tradeName>
    <deviceName>Barbiturates 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>W0102160503</emdnCode>
    <emdnDescription>BARBITURATES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBAR7001, DBAR7002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:33.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DAMP100SU</udiDi>
    <basicUdiDi>B-DAMP100SU</basicUdiDi>
    <tradeName>Amphetamine Rapid Test</tradeName>
    <deviceName>Amphetamine 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>W0102160501</emdnCode>
    <emdnDescription>AMPHETAMINES - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DAMP1001, DAMP1002, DAMP1004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-07T04:56:32.982Z</lastUpdated>
  </row>
</eudamedExport>