<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00686597202173</udiDi>
    <basicUdiDi>B-00686597202173</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab CE iten 50 and INSTI HIV Ab CE iten 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>90-1015-017 and 90-1015-018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:04:06.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201466</udiDi>
    <basicUdiDi>B-00686597201466</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test CE espten 12, INSTI HIV Self Test CE espten 350, INSTI HIV Self Test CE espten 350 and INSTI HIV Self Test CE espten 50</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>90-1060-001, 90-1060-002, 90-1060-003 and 90-1060-004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:04:05.639Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201428</udiDi>
    <basicUdiDi>B-00686597201428</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box))</tradeName>
    <deviceName>INSTI HIV Self Test CE ennoda 10 and INSTI HIV Self Test CE ennoda 250</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>90-1076-005 and 90-1076-006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:04:01.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201404</udiDi>
    <basicUdiDi>B-00686597201404</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test CE enfise 10 and INSTI HIV Self Test CE enfise 250</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>90-1076-003 and 90-1076-004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:04:00.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200636</udiDi>
    <basicUdiDi>B-00686597200636</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test CE iten 12 and INSTI HIV Self Test CE iten 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>90-1059-001 and 90-1059-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:04:00.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200414</udiDi>
    <basicUdiDi>B-00686597200414</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE fi 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>90-1015-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:59.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010761</udiDi>
    <basicUdiDi>B-00686597010761</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test</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>90-1076</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:55.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010631</udiDi>
    <basicUdiDi>B-00686597010631</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test</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>90-1063</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:54.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010600</udiDi>
    <basicUdiDi>B-00686597010600</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test</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>90-1060</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:53.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010594</udiDi>
    <basicUdiDi>B-00686597010594</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test</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>90-1059</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:52.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010587</udiDi>
    <basicUdiDi>B-00686597010587</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test</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>90-1058</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:48.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010570</udiDi>
    <basicUdiDi>B-00686597010570</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test</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>90-1057</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:48.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010563</udiDi>
    <basicUdiDi>B-00686597010563</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1056</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:35.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597010501</udiDi>
    <basicUdiDi>B-00686597010501</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0105030402</emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1050</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:03:35.145Z</lastUpdated>
  </row>
  <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>
</eudamedExport>