<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10190302018128</udiDi>
    <basicUdiDi>B-10190302018128</basicUdiDi>
    <tradeName>HIV-1 Genotyping Kit</tradeName>
    <deviceName>Applied Biosystems™ TaqPath™ Seq HIV-1 Genotyping Kit</deviceName>
    <manufacturerName>Life Technologies Corporation; Thermo Fisher Life Sciences</manufacturerName>
    <manufacturerSrn>US-MF-000026189</manufacturerSrn>
    <authorisedRepresentativeName>Life Technologies Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000021890</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A54401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:40:21.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885013956610</udiDi>
    <basicUdiDi>B-08885013956610</basicUdiDi>
    <tradeName>Sentosa SQ HIV Genotyping Assay (4x16)</tradeName>
    <deviceName>Sentosa SQ HIV Genotyping Assay (4x16)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030108</emdnCode>
    <emdnDescription>HIV 1 GENOTYPING - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>690037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T14:19:46.804Z</lastUpdated>
  </row>
</eudamedExport>