<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06926802615539</udiDi>
    <basicUdiDi>69268026MD78D000000000143</basicUdiDi>
    <tradeName>06926802615539</tradeName>
    <deviceName>Functional Fibrinogen Assay</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000005925</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MCT01501E</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:41:49.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414646664</udiDi>
    <basicUdiDi>0405686900865W7</basicUdiDi>
    <tradeName>Dade Thrombin Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874029</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:56.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414646671</udiDi>
    <basicUdiDi>0405686900865W7</basicUdiDi>
    <tradeName>Dade Thrombin Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:45:56.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>03663537084676</udiDi>
    <basicUdiDi>366353700097BW</basicUdiDi>
    <tradeName>BIOPHEN™ FVIII variant</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HYPHEN BioMed</manufacturerName>
    <manufacturerSrn>FR-MF-000002214</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>227102</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:30:02.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012320</udiDi>
    <basicUdiDi>3607450FACT0020DB</basicUdiDi>
    <tradeName>sthemO X</tradeName>
    <deviceName>sthemO X</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020209</emdnCode>
    <emdnDescription>COAGULATION FACTOR X</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01232</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:00:02.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012313</udiDi>
    <basicUdiDi>3607450FACT0019DS</basicUdiDi>
    <tradeName>sthemO VII</tradeName>
    <deviceName>sthemO VII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020205</emdnCode>
    <emdnDescription>COAGULATION FACTOR VII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01231</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T10:00:01.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012276</udiDi>
    <basicUdiDi>3607450FACT0022DF</basicUdiDi>
    <tradeName>sthemO XI</tradeName>
    <deviceName>sthemO XI</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020210</emdnCode>
    <emdnDescription>COAGULATION FACTOR XI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01227</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:57.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012269</udiDi>
    <basicUdiDi>3607450FACT0021DD</basicUdiDi>
    <tradeName>sthemO IX</tradeName>
    <deviceName>sthemO IX</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01226</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:56.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012306</udiDi>
    <basicUdiDi>3607450FACT0018DQ</basicUdiDi>
    <tradeName>sthemO V</tradeName>
    <deviceName>sthemO V</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020204</emdnCode>
    <emdnDescription>COAGULATION FACTOR V</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01230</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:55.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012290</udiDi>
    <basicUdiDi>3607450FACT0017DN</basicUdiDi>
    <tradeName>sthemO II</tradeName>
    <deviceName>sthemO II</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020202</emdnCode>
    <emdnDescription>COAGULATION FACTOR II ( PROTHROMBIN )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01229</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:55.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012252</udiDi>
    <basicUdiDi>3607450FACT0016DL</basicUdiDi>
    <tradeName>sthemO VIII</tradeName>
    <deviceName>sthemO VIII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01225</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:38.117Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450012245</udiDi>
    <basicUdiDi>36074509FIB000354</basicUdiDi>
    <tradeName>sthemO Fib M</tradeName>
    <deviceName>sthemO Fib</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01224</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:37.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007449</udiDi>
    <basicUdiDi>3607450FACT0003DB</basicUdiDi>
    <tradeName>STA® - Deficient V</tradeName>
    <deviceName>STA® - Deficient V</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020204</emdnCode>
    <emdnDescription>COAGULATION FACTOR V</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00744</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:18.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007388</udiDi>
    <basicUdiDi>3607450FACT0010D8</basicUdiDi>
    <tradeName>STA® - Deficient X</tradeName>
    <deviceName>STA® - Deficient X</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020209</emdnCode>
    <emdnDescription>COAGULATION FACTOR X</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00738</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:17.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007289</udiDi>
    <basicUdiDi>3607450FACT0006DH</basicUdiDi>
    <tradeName>STA® - ImmunoDef VIII</tradeName>
    <deviceName>STA® - ImmunoDef VIII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00728</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:16.492Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007258</udiDi>
    <basicUdiDi>3607450FACT0005DF</basicUdiDi>
    <tradeName>STA® - Deficient VIII</tradeName>
    <deviceName>STA® - Deficient VIII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00725</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:12.482Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007241</udiDi>
    <basicUdiDi>3607450FACT0008DM</basicUdiDi>
    <tradeName>STA® - Deficient IX</tradeName>
    <deviceName>STA® - Deficient IX</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00724</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:11.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450006749</udiDi>
    <basicUdiDi>36074509FIB00014Y</basicUdiDi>
    <tradeName>STA® - Fibrinogen 5</tradeName>
    <deviceName>STA® - Fibrinogen 5</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00674</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:10.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450006732</udiDi>
    <basicUdiDi>36074509FIB000252</basicUdiDi>
    <tradeName>STA® - Liquid Fib</tradeName>
    <deviceName>STA® - Liquid Fib</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00673</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T09:59:06.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437016942789</udiDi>
    <basicUdiDi>8437016942GVS-FIIFVPK</basicUdiDi>
    <tradeName>Genvinset® FIIFV multiplex 96 test</tradeName>
    <deviceName>Genvinset® FIIFV multiplex</deviceName>
    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000001091</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020299</emdnCode>
    <emdnDescription>COAGULATION FACTORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GVS-FIIFV-96</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:36:16.041Z</lastUpdated>
  </row>
</eudamedExport>