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<eudamedExport entity="devices">
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    <udiDi>08800065113019</udiDi>
    <basicUdiDi>B-08800065113019</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Blood Glucose, Hemoglobin, Lactate Monitoring System</tradeName>
    <deviceName>Blood Glucose, Hemoglobin, Lactate Monitoring System</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:53.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065110001</udiDi>
    <basicUdiDi>B-08800065110001</basicUdiDi>
    <tradeName>CERA-CHEK™ 1070 Blood Glucose Monitoring System</tradeName>
    <deviceName>CERA-CHEK™ 1070 Blood Glucose Monitoring System</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G300M10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:49.644Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065106004</udiDi>
    <basicUdiDi>B-08800065106004</basicUdiDi>
    <tradeName>CERA-CHEK™ 1Code Blood Glucose Monitoring System</tradeName>
    <deviceName>CERA-CHEK™ 1Code Blood Glucose Monitoring System</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G400M10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:11:48.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682328782008</udiDi>
    <basicUdiDi>B-08682328782008</basicUdiDi>
    <tradeName>Novacheck Blood Glucose Meter (Glucometer)</tradeName>
    <deviceName>Blood Glucose Meter (Glucometer)</deviceName>
    <manufacturerName>NOVATECH TIBBİ CİHAZ ÜRÜNLERİ SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000019017</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM-602</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:22:58.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>08588008819036</udiDi>
    <basicUdiDi>B-08588008819036</basicUdiDi>
    <tradeName>Next PRO Glukomer</tradeName>
    <deviceName>Blood Glucose Monitoring System</deviceName>
    <manufacturerName>TaiDoc Technology Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000017956</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-4125</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:29:24.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>08470001866585</udiDi>
    <basicUdiDi>B-08470001866585</basicUdiDi>
    <tradeName>lisubel®check LB-EMV3 Self Monitoring Blood Glucose System</tradeName>
    <deviceName>lisubel®check LB-EMV3 Self Monitoring Blood Glucose System</deviceName>
    <manufacturerName>EPS Bio Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000028384</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LB-EMV3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:06:30.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>08470001866509</udiDi>
    <basicUdiDi>B-08470001866509</basicUdiDi>
    <tradeName>lisubel®check LB-EMV3  Blood Glucose Meter</tradeName>
    <deviceName>lisubel®check LB-EMV3  Blood Glucose Meter</deviceName>
    <manufacturerName>EPS Bio Technology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000028384</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LB-EMV3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:06:29.705Z</lastUpdated>
  </row>
  <row>
    <udiDi>08388766478366</udiDi>
    <basicUdiDi>B-08388766478366</basicUdiDi>
    <tradeName>GluNEO plus Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>GluNEO plus Blood Glucose Monitoring System for self-testing</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFSS003KIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:10:57.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033726180680</udiDi>
    <basicUdiDi>B-08033726180680</basicUdiDi>
    <tradeName>EXADEMIN® Fast Blood Glucose Monitoring System for self-testing</tradeName>
    <deviceName>EXADEMIN® Fast Blood Glucose Monitoring System for self-testing</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>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INFM003AIT</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:28:07.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937233963</udiDi>
    <basicUdiDi>B-08032937233963</basicUdiDi>
    <tradeName>OGCare Kit (mmol/L) - HU</tradeName>
    <deviceName>OGCare Kit (mmol/L) - HU</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880003HU</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:57:28.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937233925</udiDi>
    <basicUdiDi>B-08032937233925</basicUdiDi>
    <tradeName>OGCare Kit - ENG</tradeName>
    <deviceName>OGCare Kit - ENG</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880001E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:57:27.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937233567</udiDi>
    <basicUdiDi>B-08032937233567</basicUdiDi>
    <tradeName>Aria Blood Glucose Systems Kit - English</tradeName>
    <deviceName>Aria Kit - ENG</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880005E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:57:06.623Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937233239</udiDi>
    <basicUdiDi>B-08032937233239</basicUdiDi>
    <tradeName>Aria Kit - Italiano</tradeName>
    <deviceName>Aria Kit - ITA</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880005</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:57:00.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937233215</udiDi>
    <basicUdiDi>B-08032937233215</basicUdiDi>
    <tradeName>Aria Kit</tradeName>
    <deviceName>Aria Kit - Free Sample - ITA</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880005-10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:55.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937233208</udiDi>
    <basicUdiDi>B-08032937233208</basicUdiDi>
    <tradeName>Aria Glucometer</tradeName>
    <deviceName>Aria Glucometer - ITA</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880005G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:54.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937232775</udiDi>
    <basicUdiDi>B-08032937232775</basicUdiDi>
    <tradeName>OGCare Kit - GRK</tradeName>
    <deviceName>OGCare Kit - GRK</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880001GR</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:41.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937231914</udiDi>
    <basicUdiDi>B-08032937231914</basicUdiDi>
    <tradeName>OGCare Glucometer - ITA</tradeName>
    <deviceName>OGCare Glucometer - ITA</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880001G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:34.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937231655</udiDi>
    <basicUdiDi>B-08032937231655</basicUdiDi>
    <tradeName>OGCare Kit (mmol/L) - ENG</tradeName>
    <deviceName>OGcare Kit (mmol/L) - ENG</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880003</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:33.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937231044</udiDi>
    <basicUdiDi>B-08032937231044</basicUdiDi>
    <tradeName>OGCare Kit</tradeName>
    <deviceName>OGCare Kit - ITA</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880001V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:56:21.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>08032937230047</udiDi>
    <basicUdiDi>B-08032937230047</basicUdiDi>
    <tradeName>OGCare Kit - Free Sample - Kit</tradeName>
    <deviceName>OGCare Kit - Free Sample - ITA</deviceName>
    <manufacturerName>Biochemical Systems International S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3880001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T08:53:10.790Z</lastUpdated>
  </row>
</eudamedExport>