<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00686597200766</udiDi>
    <basicUdiDi>B-00686597200766</basicUdiDi>
    <tradeName>INSTI HCV Test Controls</tradeName>
    <deviceName>INSTI HCV Test Controls CE en</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:06.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200513</udiDi>
    <basicUdiDi>B-00686597200513</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 Test Controls</tradeName>
    <deviceName>INSTI HIV-1/HIV-2 Test Controls CE enfr</deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:51.977Z</lastUpdated>
  </row>
</eudamedExport>