<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-TAFP400ZE</udiDi>
    <basicUdiDi>B-TAFP400ZE</basicUdiDi>
    <tradeName>AFP Rapid Tests</tradeName>
    <deviceName>AFP 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>W0102160299</emdnCode>
    <emdnDescription>TUMOUR MARKER RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TAFP4001, TAFP4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:40.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MPGp00NP</udiDi>
    <basicUdiDi>B-MPGp00NP</basicUdiDi>
    <tradeName>Mycoplasma pneumoniae Antigen Rapid Test</tradeName>
    <deviceName>Mycoplasma pneumoniae Antigen 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IMPGp002     IMPGp008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:35.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ITP400FY</udiDi>
    <basicUdiDi>B-ITP400FY</basicUdiDi>
    <tradeName>Syphilis Rapid Tests</tradeName>
    <deviceName>Syphilis 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>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP4001, ITP4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:34.279Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISTB4214Y</udiDi>
    <basicUdiDi>B-ISTB4214Y</basicUdiDi>
    <tradeName>Typhoid IgG/IgM Rapid Test Cassette (WB/S/P)</tradeName>
    <deviceName>Typhoid IgG/IgM 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>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTB4212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:33.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ISP100F6</udiDi>
    <basicUdiDi>B-ISP100F6</basicUdiDi>
    <tradeName>Streptococcus pneumoniae Antigen Rapid Test</tradeName>
    <deviceName>Streptococcus pneumoniae Antigen 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>W0105090109</emdnCode>
    <emdnDescription>STREP. PNEUMONIAE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISP1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:29.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRSVn00GG</udiDi>
    <basicUdiDi>B-IRSVn00GG</basicUdiDi>
    <tradeName>RSV Antigen Rapid Test Cassette (Swab)</tradeName>
    <deviceName>RSV Antigen Rapid Test Cassette (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>W0105099002</emdnCode>
    <emdnDescription>RSV - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRSVn002, IRSVn008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:28.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IROT6006U</udiDi>
    <basicUdiDi>B-IROT6006U</basicUdiDi>
    <tradeName>Rotavirus Antigen Rapid Test</tradeName>
    <deviceName>Rotavirus Antigen 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>IROT6001, IROT6002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:27.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRA621CK</udiDi>
    <basicUdiDi>B-IRA621CK</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus Antigen Triline Rapid Test</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Triline 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>IRA6212, IRA6218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:27.073Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IRA620CH</udiDi>
    <basicUdiDi>B-IRA620CH</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus Antigen Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen Combo Rapid Test Cassette (Feces)</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>IRA6205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:23.083Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IPFGi0075</udiDi>
    <basicUdiDi>B-IPFGi0075</basicUdiDi>
    <tradeName>Malaria P.f Antigen Rapid Test Cassette (WB)</tradeName>
    <deviceName>Malaria P.f Antigen Rapid Test Cassette (WB)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPFGi002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:22.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ILP100CR</udiDi>
    <basicUdiDi>B-ILP100CR</basicUdiDi>
    <tradeName>Legionella pneumophila Antigen Rapid Test</tradeName>
    <deviceName>Legionella pneumophila Antigen 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>W0105090108</emdnCode>
    <emdnDescription>LEGIONELLA - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ILP1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:16.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IID642AD</udiDi>
    <basicUdiDi>B-IID642AD</basicUdiDi>
    <tradeName>Rotavirus/Adenovirus/Norovirus Antigen Combo Rapid Test Cassette (Feces)</tradeName>
    <deviceName>Rotavirus/Adenovirus/Norovirus Antigen Combo Rapid Test Cassette (Feces)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IID6425</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:15.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHPB400WS</udiDi>
    <basicUdiDi>B-IHPB400WS</basicUdiDi>
    <tradeName>H.pylori Antibody Rapid Tests</tradeName>
    <deviceName>H.pylori Antibody 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>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHPB4001, IHPB4002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:15.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHMPn0092</udiDi>
    <basicUdiDi>B-IHMPn0092</basicUdiDi>
    <tradeName>HMPV Antigen Rapid Test</tradeName>
    <deviceName>HMPV Antigen 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHMPn002          IHMPn008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:08.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IGMq52L2</udiDi>
    <basicUdiDi>B-IGMq52L2</basicUdiDi>
    <tradeName>COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test</tradeName>
    <deviceName>COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IGMq525</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:08.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFVGi218T</udiDi>
    <basicUdiDi>B-IFVGi218T</basicUdiDi>
    <tradeName>Malaria P.f/P.v Antigen Rapid Test Cassette (WB)</tradeName>
    <deviceName>Malaria P.f/P.v Antigen Rapid Test Cassette (WB)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFVGi212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:03.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFPGi216R</udiDi>
    <basicUdiDi>B-IFPGi216R</basicUdiDi>
    <tradeName>Malaria P.f/Pan Antigen Rapid Test Cassette (WB)</tradeName>
    <deviceName>Malaria P.f/Pan Antigen Rapid Test Cassette (WB)</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>W0105090401</emdnCode>
    <emdnDescription>PLASMODIUM (MALARIA) - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFPGi212,  IFPGi218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:03.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLUn2198</udiDi>
    <basicUdiDi>B-IFLUn2198</basicUdiDi>
    <tradeName>Influenza A+B Rapid Test</tradeName>
    <deviceName>Influenza A+B 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLUn212, IFLUn218</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:02.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IFLUn2096</udiDi>
    <basicUdiDi>B-IFLUn2096</basicUdiDi>
    <tradeName>Influenza A+B Rapid Test</tradeName>
    <deviceName>Influenza A+B 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>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IFLUn205, IFLUn208</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:19:01.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IDEN432UE</udiDi>
    <basicUdiDi>B-IDEN432UE</basicUdiDi>
    <tradeName>Dengue IgG/IgM-NS1 Combo Rapid Test Cassette (WB/S/P)</tradeName>
    <deviceName>Dengue IgG/IgM-NS1 Combo 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>W0105099007</emdnCode>
    <emdnDescription>DENGUE - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IDEN4325</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-06T23:18:57.462Z</lastUpdated>
  </row>
</eudamedExport>