<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800323056171</udiDi>
    <basicUdiDi>B-08800323056171</basicUdiDi>
    <tradeName>GluNEO Lite Blood Glucose Test Strip</tradeName>
    <deviceName>GluNEO Lite Blood Glucose Test Strip</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</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>INFS001L</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:43.343Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800323056157</udiDi>
    <basicUdiDi>B-08800323056157</basicUdiDi>
    <tradeName>Oh'Care Lite Blood Glucose Test Strip</tradeName>
    <deviceName>Oh'Care Lite Blood Glucose Test Strip</deviceName>
    <manufacturerName>OSANG Healthcare Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032605</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>INFS003A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T05:22:41.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800075500588</udiDi>
    <basicUdiDi>B-08800075500588</basicUdiDi>
    <tradeName>1drop™ TBIL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>1drop Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026103</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>B20190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:22:39.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065144402</udiDi>
    <basicUdiDi>B-08800065144402</basicUdiDi>
    <tradeName>CERA-STAT™ HbA1c Test Kit</tradeName>
    <deviceName>CERA-STAT™ HbA1c Test Kit</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>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS400S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:08.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065144105</udiDi>
    <basicUdiDi>B-08800065144105</basicUdiDi>
    <tradeName>CERA-STAT™ 2000 HbA1c Test Kit</tradeName>
    <deviceName>HbA1c Test Kit</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>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:07.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065142101</udiDi>
    <basicUdiDi>B-08800065142101</basicUdiDi>
    <tradeName>LabonaCheck™ A1c HbA1c Test Kit</tradeName>
    <deviceName>HbA1c Test Kit</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>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MH200S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:06.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065133123</udiDi>
    <basicUdiDi>B-08800065133123</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Lactate Test Strip</tradeName>
    <deviceName>Lactate Test Strip</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>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400S12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:00.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065133024</udiDi>
    <basicUdiDi>B-08800065133024</basicUdiDi>
    <tradeName>CERA-CHEK™ Lactate Test Strip</tradeName>
    <deviceName>Lactate Test Strip</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>IVDD</legislation>
    <emdnCode>W0101060104</emdnCode>
    <emdnDescription>LACTATE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L400S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:00.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065130122</udiDi>
    <basicUdiDi>B-08800065130122</basicUdiDi>
    <tradeName>CERA-CHEK™ 1070 Blood Glucose Test Strip</tradeName>
    <deviceName>CERA-CHEK™ 1070 Blood Glucose Test Strip</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>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G300S10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:56.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065124121</udiDi>
    <basicUdiDi>B-08800065124121</basicUdiDi>
    <tradeName>CERA-CHEK™ 1Code Blood Glucose Test Strip</tradeName>
    <deviceName>CERA-CHEK™ 1Code Blood Glucose Test Strip</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>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G400S10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:55.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065124022</udiDi>
    <basicUdiDi>B-08800065124022</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Blood Glucose Test Strip</tradeName>
    <deviceName>Blood Glucose Test Strip</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>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400S10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:54.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800031900094</udiDi>
    <basicUdiDi>B-08800031900094</basicUdiDi>
    <tradeName>AUTODXTM HbA1c Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DxGen Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000030876</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1C100, E1C150</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:06:42.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625656</udiDi>
    <basicUdiDi>B-08683555625656</basicUdiDi>
    <tradeName>LDL-CHOLESTEROL Kit</tradeName>
    <deviceName>LDL-CHOLESTEROL Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060111</emdnCode>
    <emdnDescription>LDL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21493</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:33.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625649</udiDi>
    <basicUdiDi>B-08683555625649</basicUdiDi>
    <tradeName>HDL-CHOLESTEROL Kit</tradeName>
    <deviceName>HDL-CHOLESTEROL Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060103</emdnCode>
    <emdnDescription>HDL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21492</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:29.076Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625618</udiDi>
    <basicUdiDi>B-08683555625618</basicUdiDi>
    <tradeName>UREA-S Kit</tradeName>
    <deviceName>UREA-S Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21489</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:28.274Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625625</udiDi>
    <basicUdiDi>B-08683555625625</basicUdiDi>
    <tradeName>UREA-S Kit</tradeName>
    <deviceName>UREA-S Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21490</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:26.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625601</udiDi>
    <basicUdiDi>B-08683555625601</basicUdiDi>
    <tradeName>UREA-S Kit</tradeName>
    <deviceName>UREA-S Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21488</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:09.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625373</udiDi>
    <basicUdiDi>B-08683555625373</basicUdiDi>
    <tradeName>UPROTEIN Kit</tradeName>
    <deviceName>UPROTEIN Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21304</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:07.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625366</udiDi>
    <basicUdiDi>B-08683555625366</basicUdiDi>
    <tradeName>UPROTEIN Kit</tradeName>
    <deviceName>UPROTEIN Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060106</emdnCode>
    <emdnDescription>UREA TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21303</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:05.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555625137</udiDi>
    <basicUdiDi>B-08683555625137</basicUdiDi>
    <tradeName>HbA1c Kit</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B21174</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:55:01.722Z</lastUpdated>
  </row>
</eudamedExport>