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    <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>
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  <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>
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  <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>
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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</eudamedExport>