<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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-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-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-47136487606AHS2D</udiDi>
    <basicUdiDi>B-47136487606AHS2D</basicUdiDi>
    <tradeName>HemoSmart GOLD</tradeName>
    <deviceName>HemoSmart GOLD hemoglobin 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>S5800112</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:05.400Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487606A06A</udiDi>
    <basicUdiDi>B-47136487606A06A</basicUdiDi>
    <tradeName>HemoSmart GOLD</tradeName>
    <deviceName>HemoSmart GOLD Hemoglobin Screening 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>S25009, S25032, S25033</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:51.637Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487605AUS3D</udiDi>
    <basicUdiDi>B-47136487605AUS3D</basicUdiDi>
    <tradeName>UASure II</tradeName>
    <deviceName>UASure II 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>Piyasada</deviceStatus>
    <reference>S5800386</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:48.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487605A065</udiDi>
    <basicUdiDi>B-47136487605A065</basicUdiDi>
    <tradeName>UASure II</tradeName>
    <deviceName>UASure II/ UASure II Link Blood Uric Acid 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>S95050, S95056, S95055, S95057</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:46.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603C3SY3</udiDi>
    <basicUdiDi>B-47136487603C3SY3</basicUdiDi>
    <tradeName>Wellion AMADEUS</tradeName>
    <deviceName>Wellion AMADEUS 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>S5800475, S5800476, S5800477</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:41.228Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603C1SXV</udiDi>
    <basicUdiDi>B-47136487603C1SXV</basicUdiDi>
    <tradeName>Contrex Plus 5</tradeName>
    <deviceName>Contrex Plus 5 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>S5800301 S5800303 S5800459 S5800460 S5800461</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:35.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603C163</udiDi>
    <basicUdiDi>B-47136487603C163</basicUdiDi>
    <tradeName>GlucoSure Advance II</tradeName>
    <deviceName>GlucoSure Advance II Blood Glucose 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>Piyasada</deviceStatus>
    <reference>S70335 S70350 S70512 S70513 S70514</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:34.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603B1SXQ</udiDi>
    <basicUdiDi>B-47136487603B1SXQ</basicUdiDi>
    <tradeName>Contrex Plus 6</tradeName>
    <deviceName>Contrex Plus 6 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S5800403 S5800404 S5800405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:30.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603B15Y</udiDi>
    <basicUdiDi>B-47136487603B15Y</basicUdiDi>
    <tradeName>GlucoSure POC Compact</tradeName>
    <deviceName>GlucoSure POC Compact Blood Glucose 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S70466, S70467</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:29.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487603B05W</udiDi>
    <basicUdiDi>B-47136487603B05W</basicUdiDi>
    <tradeName>GlucoSure POC</tradeName>
    <deviceName>GlucoSure POC Blood Glucose and 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S84512, S84511</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:27.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487602AS7S</udiDi>
    <basicUdiDi>B-47136487602AS7S</basicUdiDi>
    <tradeName>Contrex Plus 4</tradeName>
    <deviceName>Contrex Plus 4 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>S5800308, S5800153, S5800309, S5800154, S5800310, S5800155</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:23.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487602A15Q</udiDi>
    <basicUdiDi>B-47136487602A15Q</basicUdiDi>
    <tradeName>GlucoSure HT Link</tradeName>
    <deviceName>GlucoSure HT Link Blood Glucose 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>S70440, S70441, S70442</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:21.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487601AS7M</udiDi>
    <basicUdiDi>B-47136487601AS7M</basicUdiDi>
    <tradeName>Contrex Plus III</tradeName>
    <deviceName>Contrex Plus III 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>S5800091</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:16.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487601A15K</udiDi>
    <basicUdiDi>B-47136487601A15K</basicUdiDi>
    <tradeName>GlucoSure Link</tradeName>
    <deviceName>GlucoSure Link Blood Glucose 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>S70453, S70454, S70455</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:13.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487601A05H</udiDi>
    <basicUdiDi>B-47136487601A05H</basicUdiDi>
    <tradeName>GlucoSure Autocode</tradeName>
    <deviceName>GlucoSure Autocode Blood Glucose 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>Piyasada</deviceStatus>
    <reference>S70123, S70488</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:55:11.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-4-86X</udiDi>
    <basicUdiDi>B-4-86X</basicUdiDi>
    <tradeName>D-4-86X</tradeName>
    <deviceName>Hemoglobin Control Solution</deviceName>
    <manufacturerName>URIT Medical Electronic Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011840</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:16.074Z</lastUpdated>
  </row>
</eudamedExport>