<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974960210004</udiDi>
    <basicUdiDi>B-06974960210004</basicUdiDi>
    <tradeName>06974960210004</tradeName>
    <deviceName>Nucleic Acid Test Kit for HBV, HCV, HIV (Type1+2) (Real-time PCR)</deviceName>
    <manufacturerName>Sanway Gene Tech. Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000037912</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070301</emdnCode>
    <emdnDescription>HBV / HCV / HIV COMBINATION - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C004E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:07:17.766Z</lastUpdated>
  </row>
</eudamedExport>