<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00686597200766</udiDi>
    <basicUdiDi>B-00686597200766</basicUdiDi>
    <tradeName>INSTI HCV Test Controls</tradeName>
    <deviceName>INSTI HCV Test Controls CE en</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1067</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:06.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200704</udiDi>
    <basicUdiDi>B-00686597200704</basicUdiDi>
    <tradeName>INSTI HCV ANTIBODY TEST</tradeName>
    <deviceName>INSTI HCV Ab Test CE fr 50 and INSTI HCV Ab Test CE fr 300</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>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1062-005 and 90-1062-006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:05.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200674</udiDi>
    <basicUdiDi>B-00686597200674</basicUdiDi>
    <tradeName>INSTI HCV ANTIBODY TEST</tradeName>
    <deviceName>INSTI HCV Ab Test CE en 25, INSTI HCV Ab Test CE en 50 and INSTI HCV Ab Test CE 300</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>W0105020303</emdnCode>
    <emdnDescription>HCV ANTIBODY (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1062-001, 90-1062-002, and 90-1062-003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:04:04.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200636</udiDi>
    <basicUdiDi>B-00686597200636</basicUdiDi>
    <tradeName>INSTI HIV ANTIBODY SELF-TEST</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>2026-07-04T15:04:00.810Z</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>00686597200513</udiDi>
    <basicUdiDi>B-00686597200513</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 Test Controls</tradeName>
    <deviceName>INSTI HIV-1/HIV-2 Test Controls CE enfr</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>W0105094001</emdnCode>
    <emdnDescription>CONTROLS INFECTIOUS IMMUNOLOGY - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1036</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:51.977Z</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>00686597200490</udiDi>
    <basicUdiDi>B-00686597200490</basicUdiDi>
    <tradeName>INSTI Multiplex HIV-1/2 Syphilis Ab Test</tradeName>
    <deviceName>INSTI Multiplex 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>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1028-009</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:47.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>00686597200483</udiDi>
    <basicUdiDi>B-00686597200483</basicUdiDi>
    <tradeName>INSTI Multiplex HIV-1/2 Syphilis Ab Test</tradeName>
    <deviceName>INSTI Multiplex 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>W0105010302</emdnCode>
    <emdnDescription>SYPHILIS ANTIBODY ASSAYS TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1028-008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:46.381Z</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>00686597200414</udiDi>
    <basicUdiDi>B-00686597200414</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST KIT</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>2026-07-04T15:03:40.760Z</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>
  <row>
    <udiDi>00686597200377</udiDi>
    <basicUdiDi>B-00686597200377</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName>INSTI HIV Ab Test CE de 50 and INSTI HIV Ab Test CE de 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>90-1015-005 and 90-1015-006</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:23.909Z</lastUpdated>
  </row>
</eudamedExport>