<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800065181100</udiDi>
    <basicUdiDi>B-08800065181100</basicUdiDi>
    <tradeName>CERA-CHEK™ Lactate Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L400C10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T01:44:08.446Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065181209</udiDi>
    <basicUdiDi>B-08800065181209</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Lactate Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400C12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T01:44:08.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065144402</udiDi>
    <basicUdiDi>B-08800065144402</basicUdiDi>
    <tradeName>CERA-STAT™ HbA1c Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS400S10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:23:28.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065178001</udiDi>
    <basicUdiDi>B-08800065178001</basicUdiDi>
    <tradeName>CERA-STAT™ HbA1c Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS400C10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T10:23:28.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065162406</udiDi>
    <basicUdiDi>B-08800065162406</basicUdiDi>
    <tradeName>LabonaCheck™ A1c HbA1c Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MH200M10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-18T03:48:55.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065168002</udiDi>
    <basicUdiDi>B-08800065168002</basicUdiDi>
    <tradeName>LabonaCheck™ A1c Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MH200C10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:56.850Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065176007</udiDi>
    <basicUdiDi>B-08800065176007</basicUdiDi>
    <tradeName>CERA-STAT™ 2000 HbA1c Control Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200C10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:56.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065142101</udiDi>
    <basicUdiDi>B-08800065142101</basicUdiDi>
    <tradeName>LabonaCheck™ A1c HbA1c Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MH200S10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:56.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065144105</udiDi>
    <basicUdiDi>B-08800065144105</basicUdiDi>
    <tradeName>CERA-STAT™ 2000 HbA1c Test Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200S10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:56.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065164004</udiDi>
    <basicUdiDi>B-08800065164004</basicUdiDi>
    <tradeName>CERA-STAT™ 2000  Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200M10</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T03:48:56.093Z</lastUpdated>
  </row>
</eudamedExport>