<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03760369291217</udiDi>
    <basicUdiDi>376036929SMI001EV</basicUdiDi>
    <tradeName>SeroQal ARCHI 7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>252202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:08:14.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000026</udiDi>
    <basicUdiDi>754022452766AY</basicUdiDi>
    <tradeName>REDx HPV 18 Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-62-18</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000064</udiDi>
    <basicUdiDi>754022452766AY</basicUdiDi>
    <tradeName>REDx HPV 45 Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-62-45</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000224</udiDi>
    <basicUdiDi>754022464748BP</basicUdiDi>
    <tradeName>REDxFLOQ SARS-CoV-2 Swab Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-S-19-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000286</udiDi>
    <basicUdiDi>754022464748BP</basicUdiDi>
    <tradeName>REDx SARS-CoV-2 Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-99-M3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000293</udiDi>
    <basicUdiDi>754022464748BP</basicUdiDi>
    <tradeName>REDxFLOQ SARS-CoV-2 Swab Negative Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-S-99-M4</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.834Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540224000316</udiDi>
    <basicUdiDi>754022464922BF</basicUdiDi>
    <tradeName>REDxFLOQ SARS-CoV-2 Ag Swab Positive Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Microbix Biosystems Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028149</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RED-S-19-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:07.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670897</udiDi>
    <basicUdiDi>426046567NTHBVScrCV</basicUdiDi>
    <tradeName>Optitrol NAT  HBV Screening</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670910</udiDi>
    <basicUdiDi>426046567NTHBVVLSQ</basicUdiDi>
    <tradeName>Optitrol NAT HBV Viral Load</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670934</udiDi>
    <basicUdiDi>426046567NTHCVScrD8</basicUdiDi>
    <tradeName>Optitrol NAT HCV Screening</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670958</udiDi>
    <basicUdiDi>426046567NTHCVVLSX</basicUdiDi>
    <tradeName>Optitrol NAT HCV Viral Load</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670972</udiDi>
    <basicUdiDi>426046567NTHIVScrFA</basicUdiDi>
    <tradeName>Optitrol NAT HIV Screening</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01032</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465670996</udiDi>
    <basicUdiDi>426046567NTHIVVLU9</basicUdiDi>
    <tradeName>Optitrol NAT HIV Viral Load</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465671016</udiDi>
    <basicUdiDi>426046567NTTriplex6Q</basicUdiDi>
    <tradeName>Optitrol NAT Triplex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01042</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465671030</udiDi>
    <basicUdiDi>426046567NTNATNEG92</basicUdiDi>
    <tradeName>Optitrol NAT NEG</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465671283</udiDi>
    <basicUdiDi>426046567NTHIV2GG</basicUdiDi>
    <tradeName>Optitrol NAT HIV-2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>4260465671467</udiDi>
    <basicUdiDi>426046567NTHEVDV</basicUdiDi>
    <tradeName>Optitrol NAT HEV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DiaMex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000037219</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT01122</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T02:12:31.097Z</lastUpdated>
  </row>
</eudamedExport>