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<eudamedExport entity="devices">
  <row>
    <udiDi>D-06936983106009W4</udiDi>
    <basicUdiDi>B-06936983106009W4</basicUdiDi>
    <tradeName>HCV Rapid Test</tradeName>
    <deviceName>HCV Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHC-402</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:24:38.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262353370049</udiDi>
    <basicUdiDi>B-04262353370049</basicUdiDi>
    <tradeName>PoET HBV</tradeName>
    <deviceName>PoET HBV</deviceName>
    <manufacturerName>Gesellschaft zur Forschung, Entwicklung  und Distribution von Diagnostika  im Blutspendewesen mbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025295</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2B-28-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:54:18.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200704</udiDi>
    <basicUdiDi>B-00686597200704</basicUdiDi>
    <tradeName>INSTI HCV ANTIBODY TEST</tradeName>
    <deviceName>INSTI HCV Ab Test CE fr 50 and INSTI HCV Ab Test CE fr 300</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1062-005 and 90-1062-006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:05.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200674</udiDi>
    <basicUdiDi>B-00686597200674</basicUdiDi>
    <tradeName>INSTI HCV ANTIBODY TEST</tradeName>
    <deviceName>INSTI HCV Ab Test CE en 25, INSTI HCV Ab Test CE en 50 and INSTI HCV Ab Test CE 300</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1062-001, 90-1062-002, and 90-1062-003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:04.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>18906074563610</udiDi>
    <basicUdiDi>8905459MHCVRT9A</basicUdiDi>
    <tradeName>MERISCREEN HCV</tradeName>
    <deviceName>MERISCREEN HCV</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPDHCV-01                   RPDHCV-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:38:50.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>18906074563603</udiDi>
    <basicUdiDi>8905459MHBSAGRTG4</basicUdiDi>
    <tradeName>MERISCREEN</tradeName>
    <deviceName>MERISCREEN HBsAg</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RPDHBV-01                                                     RPDHBV-03</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:38:48.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003891</udiDi>
    <basicUdiDi>40490550300001100TU</basicUdiDi>
    <tradeName>GENERIC HBV VIRAL LOAD VER 2.0</tradeName>
    <deviceName>GENERIC HBV VIRAL LOAD VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020216</emdnCode>
    <emdnDescription>HEPATITIS B VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR004.2-250IC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:48:15.455Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745127</udiDi>
    <basicUdiDi>150995901C39447SC</basicUdiDi>
    <tradeName>Access anti-HAV IgM</tradeName>
    <deviceName>C39447</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39447</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:55.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590745097</udiDi>
    <basicUdiDi>150995901C39444S6</basicUdiDi>
    <tradeName>Access anti-HAV</tradeName>
    <deviceName>Access anti-HAV</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020102</emdnCode>
    <emdnDescription>HAV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C39444</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:39:39.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>08685115805478</udiDi>
    <basicUdiDi>868511580PCR43JC</basicUdiDi>
    <tradeName>LyoSens  HEV qPCR Kit</tradeName>
    <deviceName>HEV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR43</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:36:28.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684595033456</udiDi>
    <basicUdiDi>868511580PCR43JC</basicUdiDi>
    <tradeName>ChainFor HEV qPCR Kit</tradeName>
    <deviceName>HEV qPCR Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020507</emdnCode>
    <emdnDescription>HEPATITIS E VIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR43</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T20:30:09.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033629923902</udiDi>
    <basicUdiDi>803362992GENHCVRT3H</basicUdiDi>
    <tradeName>08033629923902</tradeName>
    <deviceName>GEN-C Real Time</deviceName>
    <manufacturerName>Nuclear Laser Medicine srl</manufacturerName>
    <manufacturerSrn>IT-MF-000025709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105020309</emdnCode>
    <emdnDescription>HEPATITIS C VIRUS (HCV) GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AA1441/48</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T10:39:05.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452690</udiDi>
    <basicUdiDi>B-06970301452690</basicUdiDi>
    <tradeName>06970301452690</tradeName>
    <deviceName>Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WJ-1050</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:30.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452560</udiDi>
    <basicUdiDi>B-06970301452560</basicUdiDi>
    <tradeName>06970301452560</tradeName>
    <deviceName>Rapid Test for IgM Antibody to Hepatitis E Virus (Colloidal Gold Device)</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-1510</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:18.704Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452553</udiDi>
    <basicUdiDi>B-06970301452553</basicUdiDi>
    <tradeName>06970301452553</tradeName>
    <deviceName>Rapid Test for IgM Antibody to Hepatitis A Virus (Colloidal Gold Device)</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WJ-1010</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:17.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452546</udiDi>
    <basicUdiDi>B-06970301452546</basicUdiDi>
    <tradeName>06970301452546</tradeName>
    <deviceName>WANTAI HEV-Ag ELISA Plus</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020501</emdnCode>
    <emdnDescription>HEV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-7596</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:11.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452539</udiDi>
    <basicUdiDi>B-06970301452539</basicUdiDi>
    <tradeName>06970301452539</tradeName>
    <deviceName>WANTAI HEV-IgG ELISA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020504</emdnCode>
    <emdnDescription>HEV ANTIBODY IGG</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-7296</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:10.288Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452522</udiDi>
    <basicUdiDi>B-06970301452522</basicUdiDi>
    <tradeName>06970301452522</tradeName>
    <deviceName>WANTAI HEV-IgM ELISA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE-7196</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:09.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452492</udiDi>
    <basicUdiDi>B-06970301452492</basicUdiDi>
    <tradeName>06970301452492</tradeName>
    <deviceName>WANTAI HAV-IgM ELISA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020104</emdnCode>
    <emdnDescription>HAV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WA-1196</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:01.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>06970301452478</udiDi>
    <basicUdiDi>B-06970301452478</basicUdiDi>
    <tradeName>06970301452478</tradeName>
    <deviceName>AiDTM HBsAg ELISA</deviceName>
    <manufacturerName>Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040626</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-12480</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-06-29T22:26:00.685Z</lastUpdated>
  </row>
</eudamedExport>