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<eudamedExport entity="devices">
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    <udiDi>10815762020091</udiDi>
    <basicUdiDi>B-10815762020091</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D501</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:26:35.340Z</lastUpdated>
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  <row>
    <udiDi>09421902348044</udiDi>
    <basicUdiDi>B-09421902348044</basicUdiDi>
    <tradeName>extendSURETM Haemoglobin F and A2 Calibrators</tradeName>
    <deviceName>extendSURETM Haemoglobin F and A2 Calibrators</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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB110SCALAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:52.564Z</lastUpdated>
  </row>
  <row>
    <udiDi>09421902348037</udiDi>
    <basicUdiDi>B-09421902348037</basicUdiDi>
    <tradeName>extendSURE™ Haemoglobin F and A2 Controls</tradeName>
    <deviceName>extendSURE™ Haemoglobin F and A2 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>W0103010504</emdnCode>
    <emdnDescription>HAEMOGLOBIN CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HB110SSBAr</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:51:50.947Z</lastUpdated>
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    <udiDi>08809446081992</udiDi>
    <basicUdiDi>B-08809446081992</basicUdiDi>
    <tradeName>08809446081992</tradeName>
    <deviceName>careSTART™ Hb1 Strip</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>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHP-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:10:04.721Z</lastUpdated>
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  <row>
    <udiDi>08809446080988</udiDi>
    <basicUdiDi>B-08809446080988</basicUdiDi>
    <tradeName>08809446080988</tradeName>
    <deviceName>careSTART™ G6PD Biosensor Strip</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>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGS-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:10:02.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809446080971</udiDi>
    <basicUdiDi>B-08809446080971</basicUdiDi>
    <tradeName>08809446080971</tradeName>
    <deviceName>careSTART™ S1 G6PD Strip</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>W0103019001</emdnCode>
    <emdnDescription>CELLULAR ENZYME DETERMINATION REAGENTS (G-6-PDH, PYUVATE KINASE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSG-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:58.688Z</lastUpdated>
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  <row>
    <udiDi>08809446080155</udiDi>
    <basicUdiDi>B-08809446080155</basicUdiDi>
    <tradeName>08809446080155</tradeName>
    <deviceName>careSTART™ S1 Hb Strip</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>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSH-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:50.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317541020</udiDi>
    <basicUdiDi>B-08809317541020</basicUdiDi>
    <tradeName>ADAMII™-CD3/CD4/CD8 Kit</tradeName>
    <deviceName>ADAMII™-CD3/CD4/CD8 Kit</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD348K-025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:05.791Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317541006</udiDi>
    <basicUdiDi>B-08809317541006</basicUdiDi>
    <tradeName>ADAM-rWBC Kit</tradeName>
    <deviceName>ADHK-050</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADHK-050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:43:04.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317540634</udiDi>
    <basicUdiDi>B-08809317540634</basicUdiDi>
    <tradeName>ADAMII-CD34 Kit</tradeName>
    <deviceName>CD34K-025</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CD34K-025</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:37.768Z</lastUpdated>
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  <row>
    <udiDi>08809317540276</udiDi>
    <basicUdiDi>B-08809317540276</basicUdiDi>
    <tradeName>08809317540276</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADAM-rWBC &amp; ADAM-rWBC Kit</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:06.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809317540269</udiDi>
    <basicUdiDi>B-08809317540269</basicUdiDi>
    <tradeName>ADAM-rWBC Kit</tradeName>
    <deviceName>AD1K-050</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010199</emdnCode>
    <emdnDescription>REAGENTS FOR (AUTOMATED) HAEMATOLOGY ANALYZER - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD1K-050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T10:42:05.611Z</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>08800065140220</udiDi>
    <basicUdiDi>B-08800065140220</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Hemoglobin Test Strip</tradeName>
    <deviceName>Hemoglobin 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>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400S11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:02.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800065140022</udiDi>
    <basicUdiDi>B-08800065140022</basicUdiDi>
    <tradeName>CERA-CHEK™ Hb Plus Hemoglobin Test Strip</tradeName>
    <deviceName>CERA-CHEK™ Hb Plus Hemoglobin 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>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B400S10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:01.625Z</lastUpdated>
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  <row>
    <udiDi>08800037900814</udiDi>
    <basicUdiDi>B-08800037900814</basicUdiDi>
    <tradeName>08800037900814</tradeName>
    <deviceName>SimplexTAS 101 Hb Reagent Cartridge</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010601</emdnCode>
    <emdnDescription>HAEMOGLOBIN (HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0101039</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-09T21:06:00.929Z</lastUpdated>
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  <row>
    <udiDi>00630414223032</udiDi>
    <basicUdiDi>0405686900798WH</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i® Sheath/Rinse</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010105</emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10316869</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:51:00.439Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944413815834</udiDi>
    <basicUdiDi>69444138HematoryCon60DAJ</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-60D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.424Z</lastUpdated>
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  <row>
    <udiDi>06944413815841</udiDi>
    <basicUdiDi>69444138HematoryCon30DA3</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-30D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.389Z</lastUpdated>
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</eudamedExport>