<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-IHE-302NL</udiDi>
    <basicUdiDi>B-IHE-302NL</basicUdiDi>
    <tradeName>HEV IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>HEV IgG/IgM Rapid Test Cassette</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020503</emdnCode>
    <emdnDescription>HEV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHE-302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:47:37.658Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-IHE-R302AV</udiDi>
    <basicUdiDi>B-IHE-R302AV</basicUdiDi>
    <tradeName>HEV IgG/IgM Rapid Test Cassette</tradeName>
    <deviceName>HEV IgG/IgM Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020503</emdnCode>
    <emdnDescription>HEV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IHE-R302</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:09:38.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>08697962616282</udiDi>
    <basicUdiDi>B-08697962616282</basicUdiDi>
    <tradeName>SOFTEC Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit</tradeName>
    <deviceName>Hepatitis E Virus (HEV) IgG/IgM Rapid Test Kit</deviceName>
    <manufacturerName>ZET MEDİKAL TEKSTİL DIŞ TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000046897</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020503</emdnCode>
    <emdnDescription>HEV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SFHEV</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T04:21:47.987Z</lastUpdated>
  </row>
</eudamedExport>