<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08809115900593</udiDi>
    <basicUdiDi>B-08809115900593</basicUdiDi>
    <tradeName>GLUCOLAB Auto-Coding Blood Glucose Test Strip</tradeName>
    <deviceName>GLUCOLAB Auto-Coding 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>INFM22ANL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T08:56:52.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663911</udiDi>
    <basicUdiDi>B-08806134663911</basicUdiDi>
    <tradeName>GCare Glucose Control Solution</tradeName>
    <deviceName>GCare Glucose Control Solution</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0639C10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:47.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663713</udiDi>
    <basicUdiDi>B-08806134663713</basicUdiDi>
    <tradeName>GCare Glucose</tradeName>
    <deviceName>GCare Glucose</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBP110S10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:43.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663515</udiDi>
    <basicUdiDi>B-08806134663515</basicUdiDi>
    <tradeName>GREENCARE PRIME Glucose Control Solution</tradeName>
    <deviceName>GREENCARE PRIME Glucose Control Solution</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0635C10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:42.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663416</udiDi>
    <basicUdiDi>B-08806134663416</basicUdiDi>
    <tradeName>GREENCARE PRIME Blood Glucose Test Strip</tradeName>
    <deviceName>GREENCARE PRIME Blood Glucose Test Strip</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBP100S10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:41.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663218</udiDi>
    <basicUdiDi>B-08806134663218</basicUdiDi>
    <tradeName>GREENCARE LIPID TC Test Strip</tradeName>
    <deviceName>GREENCARE LIPID TC Test Strip</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060102</emdnCode>
    <emdnDescription>CHOLESTEROL TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLC100S10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:36.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663119</udiDi>
    <basicUdiDi>B-08806134663119</basicUdiDi>
    <tradeName>GREENCARE LIPID Profile Test Strip</tradeName>
    <deviceName>GREENCARE LIPID Profile Test Strip</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLP100S10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:36.128Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134660750</udiDi>
    <basicUdiDi>B-08806134660750</basicUdiDi>
    <tradeName>respons®A1c Hemoglobin A1c Test Kit</tradeName>
    <deviceName>respons®A1c Hemoglobin A1c Test Kit</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</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>963207</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:35.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134660743</udiDi>
    <basicUdiDi>B-08806134660743</basicUdiDi>
    <tradeName>PocketChem A1c Advanced Hemoglobin A1c Test Kit</tradeName>
    <deviceName>PocketChem A1c Advanced Hemoglobin A1c Test Kit</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</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>107033</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:35.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134660729</udiDi>
    <basicUdiDi>B-08806134660729</basicUdiDi>
    <tradeName>QDx A1c Advance Test kit</tradeName>
    <deviceName>QDx A1c Advance Test kit</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</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>RT100S10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:08:01.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134660712</udiDi>
    <basicUdiDi>B-08806134660712</basicUdiDi>
    <tradeName>GREENCARE A1c Hemoglobin A1c Test Kit</tradeName>
    <deviceName>GREENCARE A1c Hemoglobin A1c Test Kit</deviceName>
    <manufacturerName>GC Medical Science Corporation</manufacturerName>
    <manufacturerSrn>KR-MF-000015840</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>RT100S10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:07:59.054Z</lastUpdated>
  </row>
  <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>
</eudamedExport>