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<eudamedExport entity="devices">
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    <udiDi>++M52108131CB3</udiDi>
    <basicUdiDi>B-++M52108131CB3</basicUdiDi>
    <tradeName>EIAgen Detect HIV Combo Kit</tradeName>
    <deviceName>EIAgen Detect HIV Combo Kit</deviceName>
    <manufacturerName>ADALTIS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000028990</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>081311C / 081312C / 081315C</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:56:18.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Z133825S</udiDi>
    <basicUdiDi>B-Z133825S</basicUdiDi>
    <tradeName>D-Z133825S</tradeName>
    <deviceName>HIV 1&amp;2 Ag/Ab</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>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z13382</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:52:02.391Z</lastUpdated>
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  <row>
    <udiDi>D-Z043805J</udiDi>
    <basicUdiDi>B-Z043805J</basicUdiDi>
    <tradeName>D-Z043805J</tradeName>
    <deviceName>HIV 1&amp;2 Ag/Ab</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>W0105030404</emdnCode>
    <emdnDescription>HIV MULTIPLE AG/AB COMBI TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z04380</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:51:57.589Z</lastUpdated>
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  <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>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>08684387212175</udiDi>
    <basicUdiDi>B-08684387212175</basicUdiDi>
    <tradeName>RevoDx HIV-1/2 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1/2 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>W0105030405</emdnCode>
    <emdnDescription>HIV MULTIPLE - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202238-100</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:50.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>08684387212168</udiDi>
    <basicUdiDi>B-08684387212168</basicUdiDi>
    <tradeName>RevoDx HIV-1/2 qPCR Kit</tradeName>
    <deviceName>RevoDx HIV-1/2 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>W0105030405</emdnCode>
    <emdnDescription>HIV MULTIPLE - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IP202238-25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T22:52:46.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597202067</udiDi>
    <basicUdiDi>B-00686597202067</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE pt 50 and INSTI HIV Ab Test CE pt 350</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>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1015-015 and 90-1015-016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:47.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201947</udiDi>
    <basicUdiDi>B-00686597201947</basicUdiDi>
    <tradeName>48 INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE en 48</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>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1026-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:46.461Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201831</udiDi>
    <basicUdiDi>B-00686597201831</basicUdiDi>
    <tradeName>INSTI Multiplex HIV-1/2 Syphilis Ab Test</tradeName>
    <deviceName>INSTI Multiplex Test CE es 50 and INSTI Multiplex Test CE es 350</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>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1028-019 and 90-1028-020</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:42.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201824</udiDi>
    <basicUdiDi>B-00686597201824</basicUdiDi>
    <tradeName>48 INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE enro 48</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>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1026-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:41.651Z</lastUpdated>
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</eudamedExport>