<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-47136487699ASAU</udiDi>
    <basicUdiDi>B-47136487699ASAU</basicUdiDi>
    <tradeName>Contrex Plus</tradeName>
    <deviceName>Contrex Plus glucose control solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:10.289Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613AUT3C</udiDi>
    <basicUdiDi>B-47136487613AUT3C</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Uric Acid Test Strip</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5640832 S5640833</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:57:08.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613AUS3A</udiDi>
    <basicUdiDi>B-47136487613AUS3A</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Uric Acid Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800343 S5800346</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:51.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613ATT39</udiDi>
    <basicUdiDi>B-47136487613ATT39</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Triglyceride Test Strip</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060105</emdnCode>
    <emdnDescription>TRIGLYCERIDE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5640823 S5640821 S5640822 S5640824</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:50.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613ATS37</udiDi>
    <basicUdiDi>B-47136487613ATS37</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Triglyceride Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800342</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:50.119Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613AT88</udiDi>
    <basicUdiDi>B-47136487613AT88</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Blood Glucose Test Strip</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5640432  S5640437 S5640439 S5640431</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:46.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613ACTZK</udiDi>
    <basicUdiDi>B-47136487613ACTZK</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Cholesterol Test Strip</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5640826 S5640829 S5640825 S5640827 S5640831 S5640828 S5640830</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:45.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613ACSZH</udiDi>
    <basicUdiDi>B-47136487613ACSZH</basicUdiDi>
    <tradeName>MultiSure</tradeName>
    <deviceName>MultiSure Cholesterol Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800344 S5800345</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:44.524Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487613A062</udiDi>
    <basicUdiDi>B-47136487613A062</basicUdiDi>
    <tradeName>MultiSure GCTU</tradeName>
    <deviceName>MultiSure GCTU Monitoring System</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S81001, S81002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:43.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487612AT83</udiDi>
    <basicUdiDi>B-47136487612AT83</basicUdiDi>
    <tradeName>MultiSure GK</tradeName>
    <deviceName>MultiSure GK blood glucose test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640624, S5640451, S5640452</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:39.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487612AS7Z</udiDi>
    <basicUdiDi>B-47136487612AS7Z</basicUdiDi>
    <tradeName>MultiSure GK</tradeName>
    <deviceName>MultiSure GK glucose control solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5800192</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:38.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487612AKT27</udiDi>
    <basicUdiDi>B-47136487612AKT27</basicUdiDi>
    <tradeName>MultiSure GK</tradeName>
    <deviceName>MultiSure GK blood ketone test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640465, S5640466</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:38.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487612AKS25</udiDi>
    <basicUdiDi>B-47136487612AKS25</basicUdiDi>
    <tradeName>MultiSure GK</tradeName>
    <deviceName>MultiSure GK ketone control solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5800269</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:36.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487610ALTZR</udiDi>
    <basicUdiDi>B-47136487610ALTZR</basicUdiDi>
    <tradeName>THE EDGE</tradeName>
    <deviceName>THE EDGE blood lactate test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5638025</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:31.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487610ALSZP</udiDi>
    <basicUdiDi>B-47136487610ALSZP</basicUdiDi>
    <tradeName>THE EDGE</tradeName>
    <deviceName>THE EDGE lactate control solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5800024</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:30.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487610A05K</udiDi>
    <basicUdiDi>B-47136487610A05K</basicUdiDi>
    <tradeName>THE EDGE</tradeName>
    <deviceName>THE EDGE Blood Lactate Monitoring System</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S54108, S54153, S54154, S54155, S54156, S54157, S54158</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:30.126Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487609BKT3J</udiDi>
    <basicUdiDi>B-47136487609BKT3J</basicUdiDi>
    <tradeName>KETOSURE POC</tradeName>
    <deviceName>KETOSURE POC Blood Ketone Test Strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640894</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:25.297Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487609BKS3G</udiDi>
    <basicUdiDi>B-47136487609BKS3G</basicUdiDi>
    <tradeName>KETOSURE POC</tradeName>
    <deviceName>KETOSURE POC Ketone Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5800358</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:24.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487609A06R</udiDi>
    <basicUdiDi>B-47136487609A06R</basicUdiDi>
    <tradeName>KET-1</tradeName>
    <deviceName>KET-1 Blood Ketone Monitoring System</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S11004, S11008, S11009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:18.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487608BURS3Q</udiDi>
    <basicUdiDi>B-47136487608BURS3Q</basicUdiDi>
    <tradeName>Eclipse PLUS</tradeName>
    <deviceName>Eclipse PLUS Urine Control Solution</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106020601</emdnCode>
    <emdnDescription>URINE TESTING CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800401 S5800402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:18.088Z</lastUpdated>
  </row>
</eudamedExport>