<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>++M52108131CB3</udiDi>
    <basicUdiDi>B-++M52108131CB3</basicUdiDi>
    <tradeName>EIAgen Detect HIV Combo Kit</tradeName>
    <deviceName>EIAgen Detect HIV Combo Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081311C / 081312C / 081315C</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:18.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M52107106LG</udiDi>
    <basicUdiDi>B-++M52107106LG</basicUdiDi>
    <tradeName>EIAgen HCV Ab (v.4) Kit</tradeName>
    <deviceName>EIAgen HCV Ab (v.4)</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>071067 / 071064 / 071068</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:18.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M52108114LN</udiDi>
    <basicUdiDi>B-++M52108114LN</basicUdiDi>
    <tradeName>EIAgen Syphilis Ab Kit</tradeName>
    <deviceName>EIAgen Syphilis Ab Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081141 / 081142 / 081145</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:48:33.042Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M521071045</udiDi>
    <basicUdiDi>B-++M521071045</basicUdiDi>
    <tradeName>EIAgen HBsAg Kit</tradeName>
    <deviceName>EIAgen HBsAg  Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105020201</emdnCode>
    <emdnDescription>HEPATITIS B SURFACE ANTIGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>071011 / 071012 / 071015</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:48:29.033Z</lastUpdated>
  </row>
</eudamedExport>