<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974323018322</udiDi>
    <basicUdiDi>B-06974323018322</basicUdiDi>
    <tradeName>06974323018322</tradeName>
    <deviceName>Hepatitis E Virus IgM Antibody Rapid Test Cassette (Colloidal Gold Method)</deviceName>
    <manufacturerName>Beijing Applied Biological Technologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012338</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IH008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:01:36.221Z</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>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>06903053049184</udiDi>
    <basicUdiDi>69449040AB74000415J</basicUdiDi>
    <tradeName>Hepatitis E Virus IgM Antibody (CLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-038867-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:31.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155807147</udiDi>
    <basicUdiDi>B-06936155807147</basicUdiDi>
    <tradeName>Rapid Anti-HEV-IgM Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP091101-DS50</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:14:23.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936155803712</udiDi>
    <basicUdiDi>B-06936155803712</basicUdiDi>
    <tradeName>Rapid Anti-HEV-IgM Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ITP091101-TC40</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:12:35.435Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262351593051</udiDi>
    <basicUdiDi>B-04262351593051</basicUdiDi>
    <tradeName>abia HEV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AB Diagnostic Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK.030.05.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:42:04.354Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262351593013</udiDi>
    <basicUdiDi>B-04262351593013</basicUdiDi>
    <tradeName>abia HEV IgM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AB Diagnostic Systems GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025407</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105020505</emdnCode>
    <emdnDescription>HEV ANTIBODY IGM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK.030.01.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T02:42:03.458Z</lastUpdated>
  </row>
</eudamedExport>