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<eudamedExport entity="devices">
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    <udiDi>08800069130029</udiDi>
    <basicUdiDi>B-08800069130029</basicUdiDi>
    <tradeName>08800069130029</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SG BioScience Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009362</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040619</emdnCode>
    <emdnDescription>CORONAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R3002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:59.321Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066600082</udiDi>
    <basicUdiDi>B-08800066600082</basicUdiDi>
    <tradeName>Zeus Wave</tradeName>
    <deviceName>Zeus Wave(Piezo-Type+Pneumatic-Type)</deviceName>
    <manufacturerName>Wever Instruments. Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000008615</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12139001</emdnCode>
    <emdnDescription>SHOCK WAVE THERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZW-IFU-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:58.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066500283</udiDi>
    <basicUdiDi>B-08800066500283</basicUdiDi>
    <tradeName>08800066500283</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plasmapp Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012193</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>S900199</emdnCode>
    <emdnDescription>DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STERLINK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:57.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066500030</udiDi>
    <basicUdiDi>B-08800066500030</basicUdiDi>
    <tradeName>08800066500030</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plasmapp Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012193</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STERMATE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:53.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066500023</udiDi>
    <basicUdiDi>B-08800066500023</basicUdiDi>
    <tradeName>08800066500023</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plasmapp Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012193</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STERMATE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:52.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800066500016</udiDi>
    <basicUdiDi>B-08800066500016</basicUdiDi>
    <tradeName>08800066500016</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plasmapp Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000012193</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>S900101</emdnCode>
    <emdnDescription>HYDROGEN PEROXIDE CARTRIDGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STERMATE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:52.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065701018</udiDi>
    <basicUdiDi>B-08800065701018</basicUdiDi>
    <tradeName>Dr.Oppel</tradeName>
    <deviceName>High Frequency Electrosurgical Device including electrode and associated accessories</deviceName>
    <manufacturerName>Sometech Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023076</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ST-501</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:51.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065181209</udiDi>
    <basicUdiDi>B-08800065181209</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Lactate Control Solution</tradeName>
    <deviceName>Lactate 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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400C12</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:47.324Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065181100</udiDi>
    <basicUdiDi>B-08800065181100</basicUdiDi>
    <tradeName>CERA-CHEK™ Lactate Control Solution</tradeName>
    <deviceName>Lactate 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>L400C10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:46.513Z</lastUpdated>
  </row>
  <row>
    <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>08800065180004</udiDi>
    <basicUdiDi>B-08800065180004</basicUdiDi>
    <tradeName>CERA-STAT™ CRP Control Solution</tradeName>
    <deviceName>CERA-STAT™ CRP 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>W0102152003</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS400C20</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:44.906Z</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>08800065166008</udiDi>
    <basicUdiDi>B-08800065166008</basicUdiDi>
    <tradeName>CERA-STAT™ 4000 Analyzer</tradeName>
    <deviceName>CERA-STAT™ 4000 Analyzer</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>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS400M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:33.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065170203</udiDi>
    <basicUdiDi>B-08800065170203</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Hemoglobin Control Solution</tradeName>
    <deviceName>Hemoglobin 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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400C11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:32.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065170005</udiDi>
    <basicUdiDi>B-08800065170005</basicUdiDi>
    <tradeName>CERA-CHEK™ Hb Plus Hemoglobin Control Solution</tradeName>
    <deviceName>CERA-CHEK™ Hb Plus Hemoglobin 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 Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B400C10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:32.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065164004</udiDi>
    <basicUdiDi>B-08800065164004</basicUdiDi>
    <tradeName>CERA-STAT™ 2000  Analyzer</tradeName>
    <deviceName>Glycated Hemoglobin Measuring Analyzer</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>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>CS200M10</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:15.227Z</lastUpdated>
  </row>
</eudamedExport>