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<eudamedExport entity="devices">
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    <udiDi>08800065181001</udiDi>
    <basicUdiDi>B-08800065181001</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Glucose Control Solution</tradeName>
    <deviceName>Glucose Control Solution</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400C10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:45.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065178001</udiDi>
    <basicUdiDi>B-08800065178001</basicUdiDi>
    <tradeName>CERA-STAT™ HbA1c Control Solution</tradeName>
    <deviceName>CERA-STAT™ HbA1c Control Solution</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS400C10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:40.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065176007</udiDi>
    <basicUdiDi>B-08800065176007</basicUdiDi>
    <tradeName>CERA-STAT™ 2000 HbA1c Control Solution</tradeName>
    <deviceName>HbA1c Control Solution</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200C10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:40.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065174003</udiDi>
    <basicUdiDi>B-08800065174003</basicUdiDi>
    <tradeName>CERA-CHEK™ 1Code Glucose Control Solution</tradeName>
    <deviceName>CERA-CHEK™ 1Code Glucose Control Solution</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G400C10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:39.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065172009</udiDi>
    <basicUdiDi>B-08800065172009</basicUdiDi>
    <tradeName>CERA-CHEK™ 1070 Glucose Control Solution</tradeName>
    <deviceName>CERA-CHEK™ 1070 Glucose Control Solution</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G300C10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:38.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065168002</udiDi>
    <basicUdiDi>B-08800065168002</basicUdiDi>
    <tradeName>LabonaCheck™ A1c Control Solution</tradeName>
    <deviceName>HbA1c Control Solution</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>MH200C10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:34.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281843</udiDi>
    <basicUdiDi>B-08699015281843</basicUdiDi>
    <tradeName>IGE TÜRBİDİMETRİK KONTROL SET</tradeName>
    <deviceName>IGE TURBIDIMETRIC CONTROL SET</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R98-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:58.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281829</udiDi>
    <basicUdiDi>B-08699015281829</basicUdiDi>
    <tradeName>HBA1C KONTROL SET</tradeName>
    <deviceName>HBA1C CONTROL SET</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R96-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:54.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281799</udiDi>
    <basicUdiDi>B-08699015281799</basicUdiDi>
    <tradeName>CK-MB KONTROL SEVİYE II</tradeName>
    <deviceName>CK-MB CONTROL LEVEL II</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R93-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:48.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281782</udiDi>
    <basicUdiDi>B-08699015281782</basicUdiDi>
    <tradeName>CK-MB KONTROL SEVİYE I</tradeName>
    <deviceName>CK-MB CONTROL LEVEL I</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R92-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:47.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>08683555616289</udiDi>
    <basicUdiDi>B-08683555616289</basicUdiDi>
    <tradeName>URINARY PROTEIN Kit</tradeName>
    <deviceName>URINARY PROTEIN 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>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B33300</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:43:27.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812534383</udiDi>
    <basicUdiDi>B-08681812534383</basicUdiDi>
    <tradeName>MİKROALBÜMİN KONTROL</tradeName>
    <deviceName>MICROALBUMIN CONTROL</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A302M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:14.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526340</udiDi>
    <basicUdiDi>B-08681812526340</basicUdiDi>
    <tradeName>ÇİNKO KONTROL SEVİYE II</tradeName>
    <deviceName>ZINC CONTROL LEVEL II</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06R71-11</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:18.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526333</udiDi>
    <basicUdiDi>B-08681812526333</basicUdiDi>
    <tradeName>ÇİNKO KONTROL SEVİYE I</tradeName>
    <deviceName>ZINC CONTROL LEVEL I</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06R71-10</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:17.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526319</udiDi>
    <basicUdiDi>B-08681812526319</basicUdiDi>
    <tradeName>D-DİMER KONTROL SET</tradeName>
    <deviceName>D-DIMER CONTROL SET</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T04-10</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:16.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526142</udiDi>
    <basicUdiDi>B-08681812526142</basicUdiDi>
    <tradeName>SPESİFİK PROTEİN KONTROL SEVİYE II (ROMATOİD KONTROL II)</tradeName>
    <deviceName>SPECIFIC PROTEIN CONTROL LEVEL II (RHEUMATOID CONTROL II)</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T81-68</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:40:24.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526135</udiDi>
    <basicUdiDi>B-08681812526135</basicUdiDi>
    <tradeName>SPESİFİK PROTEİN KONTROL SEVİYE I (ROMATOİD KONTROL I)</tradeName>
    <deviceName>SPECIFIC PROTEIN CONTROL LEVEL I (RHEUMATOID CONTROL I)</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T81-67</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:40:23.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526128</udiDi>
    <basicUdiDi>B-08681812526128</basicUdiDi>
    <tradeName>SPESİFİK PROTEİN KONTROL SEVİYE II (ROMATOİD KONTROL II)</tradeName>
    <deviceName>SPECIFIC PROTEIN CONTROL LEVEL II (RHEUMATOID CONTROL II)</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T81-66</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:40:19.686Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812526111</udiDi>
    <basicUdiDi>B-08681812526111</basicUdiDi>
    <tradeName>SPESİFİK PROTEİN KONTROL SEVİYE I (ROMATOİD KONTROL I)</tradeName>
    <deviceName>SPECIFIC PROTEIN CONTROL LEVEL I (RHEUMATOID CONTROL I)</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06T81-65</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:40:18.888Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437022705156</udiDi>
    <basicUdiDi>B-08437022705156</basicUdiDi>
    <tradeName>Kit Control OSAXYL</tradeName>
    <deviceName>OSAXYL Control Kit</deviceName>
    <manufacturerName>BIOLAN MICROBIOSENSORES S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000001992</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KCXYL</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:00:18.668Z</lastUpdated>
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</eudamedExport>