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<eudamedExport entity="devices">
  <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>
  </row>
  <row>
    <udiDi>00686597201794</udiDi>
    <basicUdiDi>B-00686597201794</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a pouch)</tradeName>
    <deviceName>INSTI HIV Self Test CE bgen 10 and INSTI HIV Self Test CE bgen 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>90-1041-014 and 90-1041-015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:40.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201770</udiDi>
    <basicUdiDi>B-00686597201770</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in pouch)</tradeName>
    <deviceName>INSTI HIV Self Test CE roen 10 and INSTI HIV Self Test CE roen 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>90-1041-012 and 90-1041-013</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:40.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201763</udiDi>
    <basicUdiDi>B-00686597201763</basicUdiDi>
    <tradeName>48 INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE pt 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>90-1026-003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:24.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201664</udiDi>
    <basicUdiDi>B-00686597201664</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV  Ab Test CE ee 50 and INSTI HIV  Ab Test CE ee 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>90-1015-013 and 90-1015-014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:24.037Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597201244</udiDi>
    <basicUdiDi>B-00686597201244</basicUdiDi>
    <tradeName>INSTI HIV ANTIBODY SELF-TEST</tradeName>
    <deviceName>INSTI HIV Self Test CE elenru 10 and INSTI HIV Self Test CE elenru 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>90-1126-001 and 90-1126-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:11.998Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200889</udiDi>
    <basicUdiDi>B-00686597200889</basicUdiDi>
    <tradeName>INSTI HIV ANTIBODY SELF-TEST</tradeName>
    <deviceName>INSTI HIV Self Test CE eelvlt 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>90-1123-001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:11.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200858</udiDi>
    <basicUdiDi>B-00686597200858</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST KIT</tradeName>
    <deviceName>INSTI HIV-1/HIV-2 ANTIBODY TEST KIT</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</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:07.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200612</udiDi>
    <basicUdiDi>B-00686597200612</basicUdiDi>
    <tradeName>INSTI HIV ANTIBODY SELF-TEST</tradeName>
    <deviceName>INSTI HIV Self Test CE enfr 12 and INSTI HIV Self Test CE enfr 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>90-1058-001 and 90-1058-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:00.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200599</udiDi>
    <basicUdiDi>B-00686597200599</basicUdiDi>
    <tradeName>INSïl HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test CE ende 12 and INSTI HIV Self Test CE ende 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>90-1057-001 and 90-1057-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:59.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200575</udiDi>
    <basicUdiDi>B-00686597200575</basicUdiDi>
    <tradeName>INSïl HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName>INSTI HIV Self Test CE benelux 12 and INSTI HIV Self Test CE benelux 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>90-1056-001 and 90-1056-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:58.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200568</udiDi>
    <basicUdiDi>B-00686597200568</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a pouch)</tradeName>
    <deviceName>INSTI HIV Self Test CE csplsken 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>90-1041-007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:54.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200544</udiDi>
    <basicUdiDi>B-00686597200544</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a pouch)</tradeName>
    <deviceName>INSTI HIV Self Test UK en 250 and INSTI HIV Self Test UK en 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>90-1041-003 and 90-1041-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:53.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200520</udiDi>
    <basicUdiDi>B-00686597200520</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a pouch)</tradeName>
    <deviceName>INSTI HIV Self Test CE en 10 and INSTI HIV Self Test CE en 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>90-1041-001 and 90-1041-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:52.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200506</udiDi>
    <basicUdiDi>B-00686597200506</basicUdiDi>
    <tradeName>INSTI Multiplex HIV-1/2 Syphilis Ab Test</tradeName>
    <deviceName>INSTI Multiplex 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>90-1028-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:47.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200445</udiDi>
    <basicUdiDi>B-00686597200445</basicUdiDi>
    <tradeName>INSTI Multiplex HIV-1/2 Syphilis Ab Test</tradeName>
    <deviceName>INSTI Multiplex Test CE fr 50 and INSTI Multiplex Test CE fr 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>90-1028-003 and 90-1028-004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:45.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200421</udiDi>
    <basicUdiDi>B-00686597200421</basicUdiDi>
    <tradeName>INSTI Multiplex HIV-1/2 Syphilis Ab Test</tradeName>
    <deviceName>INSTI Multiplex Test CE en 50 and INSTI Multiplex Test CE en 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>90-1028-001 and 90-1028-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:41.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200407</udiDi>
    <basicUdiDi>B-00686597200407</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE BE fr 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>90-1015-009</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:39.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200391</udiDi>
    <basicUdiDi>B-00686597200391</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE cs 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>90-1015-008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:39.169Z</lastUpdated>
  </row>
</eudamedExport>