<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>+ENTICOVA094000</udiDi>
    <basicUdiDi>B-+ENTICOVA094000</basicUdiDi>
    <tradeName>+ENTICOVA094000</tradeName>
    <deviceName>NovaLisa® SARS-CoV-2 (COVID-19) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041105</emdnCode>
    <emdnDescription>CORONAVIRUS IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COVA0940</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:10:41.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI301774460S</udiDi>
    <basicUdiDi>B-+ENTI301774460S</basicUdiDi>
    <tradeName>+ENTI301774460S</tradeName>
    <deviceName>SARS-CoV-2 (COVID-19) IgA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041105</emdnCode>
    <emdnDescription>CORONAVIRUS IGA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30177446</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:06:50.564Z</lastUpdated>
  </row>
</eudamedExport>