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<eudamedExport entity="devices">
  <row>
    <udiDi>D-Z035024Z</udiDi>
    <basicUdiDi>B-Z035024Z</basicUdiDi>
    <tradeName>D-Z035024Z</tradeName>
    <deviceName>HIV 1&amp;2 Ab, cut-off</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z03502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:52.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Z0137554</udiDi>
    <basicUdiDi>B-Z0137554</basicUdiDi>
    <tradeName>D-Z0137554</tradeName>
    <deviceName>HIV 1&amp;2 Ab, cut-off</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z01375</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:51.987Z</lastUpdated>
  </row>
  <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>
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  <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>D-MARSA-10NU</udiDi>
    <basicUdiDi>B-MARSA-10NU</basicUdiDi>
    <tradeName>MRSA/SA Test</tradeName>
    <deviceName>MRSA/SA Test</deviceName>
    <manufacturerName>FlashDx Shenzhen Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000025748</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030704</emdnCode>
    <emdnDescription>HTLV MULTIPLE - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MARSA-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:14.922Z</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>09349609001126</udiDi>
    <basicUdiDi>B-09349609001126</basicUdiDi>
    <tradeName>09349609001126</tradeName>
    <deviceName>Atomo HIV Self Test</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARST001-04</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:52.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609001140</udiDi>
    <basicUdiDi>B-09349609001140</basicUdiDi>
    <tradeName>09349609001140</tradeName>
    <deviceName>Atomo HIV Self Test</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARST001-05</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:51.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609001102</udiDi>
    <basicUdiDi>B-09349609001102</basicUdiDi>
    <tradeName>09349609001102</tradeName>
    <deviceName>Newfoundland HIV Self Test</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NFLD001-03</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:33.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609000969</udiDi>
    <basicUdiDi>B-09349609000969</basicUdiDi>
    <tradeName>09349609000969</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NFLD001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:32.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609000952</udiDi>
    <basicUdiDi>B-09349609000952</basicUdiDi>
    <tradeName>09349609000952</tradeName>
    <deviceName>Newfoundland HIV Self Test</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NFLD001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:28.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609000938</udiDi>
    <basicUdiDi>B-09349609000938</basicUdiDi>
    <tradeName>Newfoundland HIV Self  Test</tradeName>
    <deviceName>Newfoundland HIV Self  Test (ENG)</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NFLD001-01</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:27.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609000600</udiDi>
    <basicUdiDi>B-09349609000600</basicUdiDi>
    <tradeName>Simplitude ByMe</tradeName>
    <deviceName>HIV Self Test</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P003948A1-10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:26.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609000204</udiDi>
    <basicUdiDi>B-09349609000204</basicUdiDi>
    <tradeName>Simplitude ByMe</tradeName>
    <deviceName>HIV Self Test</deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P002514A1-10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:25.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>09349609000082</udiDi>
    <basicUdiDi>B-09349609000082</basicUdiDi>
    <tradeName>09349609000082</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atomo Diagnostics Limited</manufacturerName>
    <manufacturerSrn>AU-MF-000024146</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARST001-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:47:22.597Z</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>08684387215114</udiDi>
    <basicUdiDi>B-08684387215114</basicUdiDi>
    <tradeName>RevoDx HIV-2 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-2 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>W0105030204</emdnCode>
    <emdnDescription>HIV 2 - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202236-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T23:03:53.549Z</lastUpdated>
  </row>
</eudamedExport>