<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06976753475591</udiDi>
    <basicUdiDi>B-06976753475591</basicUdiDi>
    <tradeName>HEV IgM Rapid Test Device (Serum/Plasma)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020501</emdnCode>
    <emdnDescription>HEV ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A401401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:17.914Z</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>
</eudamedExport>