<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07332940007461</udiDi>
    <basicUdiDi>B-07332940007461</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HIV-1 Qual XC</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHIV-QA-XC-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:08.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>07332940007409</udiDi>
    <basicUdiDi>B-07332940007409</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® HIV-1 Viral Load XC</deviceName>
    <manufacturerName>Cepheid AB</manufacturerName>
    <manufacturerSrn>SE-MF-000002020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXHIV-VL-XC-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:56:06.598Z</lastUpdated>
  </row>
  <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>
  <row>
    <udiDi>08698898740058</udiDi>
    <basicUdiDi>B-08698898740058</basicUdiDi>
    <tradeName>Fluorion</tradeName>
    <deviceName>Fluorion HIV-1 QNP 1.1 Real-Time PCR Kit</deviceName>
    <manufacturerName>IONTEK ILAC TANI VE BIYOTEKNOLOJI URUNLERI AR. GE. SAN. TIC. A.S.</manufacturerName>
    <manufacturerSrn>TR-MF-000023054</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0290202</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:59:54.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215657</udiDi>
    <basicUdiDi>B-08684387215657</basicUdiDi>
    <tradeName>RevoDx HIV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201924-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:48.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387215640</udiDi>
    <basicUdiDi>B-08684387215640</basicUdiDi>
    <tradeName>RevoDx HIV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201924-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:05:48.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212076</udiDi>
    <basicUdiDi>B-08684387212076</basicUdiDi>
    <tradeName>RevoDx HIV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-250</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:33.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212069</udiDi>
    <basicUdiDi>B-08684387212069</basicUdiDi>
    <tradeName>RevoDx HIV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:17.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212052</udiDi>
    <basicUdiDi>B-08684387212052</basicUdiDi>
    <tradeName>RevoDx HIV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:17.009Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212045</udiDi>
    <basicUdiDi>B-08684387212045</basicUdiDi>
    <tradeName>RevoDx HIV-1 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1 qPCR Kit</deviceName>
    <manufacturerName>İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000047330</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP201903-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:16.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696303976</udiDi>
    <basicUdiDi>B-08595696303976</basicUdiDi>
    <tradeName>TaqPath™ Menu | GeneProof™ HIV type 1 (HIV-1) Diagnostic PCR Kit</tradeName>
    <deviceName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A58119</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:59:06.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300821</udiDi>
    <basicUdiDi>B-08595696300821</basicUdiDi>
    <tradeName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</tradeName>
    <deviceName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIV1D/GP/100</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:58.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08595696300807</udiDi>
    <basicUdiDi>B-08595696300807</basicUdiDi>
    <tradeName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</tradeName>
    <deviceName>GeneProof HIV type 1 (HIV-1) Diagnostic PCR kit</deviceName>
    <manufacturerName>GeneProof a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000002370</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HIV1D/GP/025</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:57:54.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049055003907</udiDi>
    <basicUdiDi>40490550300001105U6</basicUdiDi>
    <tradeName>GENERIC HIV-1 VIRAL LOAD VER 2.0</tradeName>
    <deviceName>GENERIC HIV-1 VIRAL LOAD VER 2.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TR001.2-192</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:48:19.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>06955792731295</udiDi>
    <basicUdiDi>B-06955792731295</basicUdiDi>
    <tradeName>Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit  (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Human Immunodeficiency Virus Type 1 RNA Quantitative Fluorescence Diagnostic Kit  (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030107</emdnCode>
    <emdnDescription>HIV 1 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3046E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:30:48.960Z</lastUpdated>
  </row>
</eudamedExport>