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<eudamedExport entity="devices">
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    <udiDi>D-1001877566</udiDi>
    <basicUdiDi>B-1001877566</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Control 3</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Control 3</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018775</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:59.829Z</lastUpdated>
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  <row>
    <udiDi>D-1001877464</udiDi>
    <basicUdiDi>B-1001877464</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Control 2</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Control 2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018774</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:54.228Z</lastUpdated>
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  <row>
    <udiDi>D-1001877362</udiDi>
    <basicUdiDi>B-1001877362</basicUdiDi>
    <tradeName>Cascadion™ SM Immunosuppressants Panel Control 1</tradeName>
    <deviceName>Cascadion™ SM Immunosuppressants Panel Control 1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018773</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:53.431Z</lastUpdated>
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  <row>
    <udiDi>D-100187635X</udiDi>
    <basicUdiDi>B-100187635X</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Control 3</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Control 3</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018763</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:35.771Z</lastUpdated>
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  <row>
    <udiDi>D-100187625V</udiDi>
    <basicUdiDi>B-100187625V</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Control 2</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Control 2</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018762</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:34.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-100187615T</udiDi>
    <basicUdiDi>B-100187615T</basicUdiDi>
    <tradeName>Cascadion™ SM 25-Hydroxy Vitamin D Control 1</tradeName>
    <deviceName>Cascadion™ SM 25-Hydroxy Vitamin D Control 1</deviceName>
    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000001479</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>10018761</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:35:34.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348099</udiDi>
    <basicUdiDi>B-09421902348099</basicUdiDi>
    <tradeName>extendSURE™ HbA1c Liquid Controls</tradeName>
    <deviceName>extendSURE™ HbA1c Liquid Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12397</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:56.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348075</udiDi>
    <basicUdiDi>B-09421902348075</basicUdiDi>
    <tradeName>extendSURETM Haemoglobin A1c Lyophilised Controls</tradeName>
    <deviceName>extendSURETM Haemoglobin A1c Lyophilised Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB710SBAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:54.858Z</lastUpdated>
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  <row>
    <udiDi>09421902348006</udiDi>
    <basicUdiDi>B-09421902348006</basicUdiDi>
    <tradeName>extendSURE™ HbA1c Liquid Controls</tradeName>
    <deviceName>extendSURE™ HbA1c Liquid Controls</deviceName>
    <manufacturerName>Canterbury Scientific Limited</manufacturerName>
    <manufacturerSrn>NZ-MF-000001778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B12396</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:50.110Z</lastUpdated>
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  <row>
    <udiDi>08809446080964</udiDi>
    <basicUdiDi>B-08809446080964</basicUdiDi>
    <tradeName>08809446080964</tradeName>
    <deviceName>careSTART™ Total Bilirubin Biosensor Control</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050203</emdnCode>
    <emdnDescription>BILIRUBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HCB-N05082</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:57.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809446080704</udiDi>
    <basicUdiDi>B-08809446080704</basicUdiDi>
    <tradeName>08809446080704</tradeName>
    <deviceName>careSTART™ G6PD Biosensor Control Level II</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGT-N05082</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:57.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809446080698</udiDi>
    <basicUdiDi>B-08809446080698</basicUdiDi>
    <tradeName>08809446080698</tradeName>
    <deviceName>careSTART™ G6PD Biosensor Control Level I</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGO-N05082</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:56.634Z</lastUpdated>
  </row>
  <row>
    <udiDi>08806134663317</udiDi>
    <basicUdiDi>B-08806134663317</basicUdiDi>
    <tradeName>GREENCARE LIPID Control Solution</tradeName>
    <deviceName>GREENCARE LIPID 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>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0633C10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T06:09:40.928Z</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>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>
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