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<eudamedExport entity="devices">
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    <basicUdiDi>B-00816426021099</basicUdiDi>
    <tradeName>K-ASSAY Factor XIII Control</tradeName>
    <deviceName>Factor XIII Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K135C-10M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:39:07.699Z</lastUpdated>
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    <udiDi>00816426020719</udiDi>
    <basicUdiDi>B-00816426020719</basicUdiDi>
    <tradeName>K-ASSAY Factor XIII Calibrator</tradeName>
    <deviceName>Factor XIII Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-106C</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:54.099Z</lastUpdated>
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  <row>
    <udiDi>00816426020467</udiDi>
    <basicUdiDi>B-00816426020467</basicUdiDi>
    <tradeName>K-ASSAY Factor XIII</tradeName>
    <deviceName>Factor XIII Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-105</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:34.079Z</lastUpdated>
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    <udiDi>08426950925743</udiDi>
    <basicUdiDi>84269509257439V</basicUdiDi>
    <tradeName>HemosIL AcuStar VWF:CB</tradeName>
    <deviceName>HemosIL AcuStar VWF:CB</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020218</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND COLLAGEN BINDING ASSAY (CBA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802044</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:13:06.765Z</lastUpdated>
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  <row>
    <udiDi>08426950585008</udiDi>
    <basicUdiDi>842695058500896</basicUdiDi>
    <tradeName>HemosIL AcuStar VWF:RCo</tradeName>
    <deviceName>HemosIL AcuStar VWF:RCo</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020217</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND ACTIVITY / RISTOCETIN COFACTOR ACTIVITY (RCO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802024</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:17.011Z</lastUpdated>
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  <row>
    <udiDi>08426950584995</udiDi>
    <basicUdiDi>8426950584995AZ</basicUdiDi>
    <tradeName>HemosIL AcuStar VWF:Ag</tradeName>
    <deviceName>HemosIL AcuStar VWF:Ag</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:16.197Z</lastUpdated>
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    <udiDi>08426950573500</udiDi>
    <basicUdiDi>84269505735008N</basicUdiDi>
    <tradeName>HemosIL Q.F.A. Thrombin (Bovine)</tradeName>
    <deviceName>HemosIL Q.F.A. Thrombin (Bovine)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:10:51.386Z</lastUpdated>
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  <row>
    <udiDi>08426950573494</udiDi>
    <basicUdiDi>84269505734949L</basicUdiDi>
    <tradeName>HemosIL Q.F.A. Thrombin (Bovine)</tradeName>
    <deviceName>HemosIL Q.F.A. Thrombin (Bovine)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:10:50.572Z</lastUpdated>
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  <row>
    <udiDi>08426950545378</udiDi>
    <basicUdiDi>84269505453788W</basicUdiDi>
    <tradeName>HemosIL VWF:RCo</tradeName>
    <deviceName>HemosIL VWF:RCo</deviceName>
    <manufacturerName>Biokit S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000002406</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020217</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND ACTIVITY / RISTOCETIN COFACTOR ACTIVITY (RCO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020300900</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:11.646Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950491392</udiDi>
    <basicUdiDi>842695049139296</basicUdiDi>
    <tradeName>HemosIL Factor VII deficient plasma</tradeName>
    <deviceName>HemosIL Factor VII deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020205</emdnCode>
    <emdnDescription>COAGULATION FACTOR VII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020011700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:23.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950491385</udiDi>
    <basicUdiDi>842695049138599</basicUdiDi>
    <tradeName>HemosIL Factor X deficient plasma</tradeName>
    <deviceName>HemosIL Factor X deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020209</emdnCode>
    <emdnDescription>COAGULATION FACTOR X</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020010000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:19.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950491378</udiDi>
    <basicUdiDi>84269504913789C</basicUdiDi>
    <tradeName>HemosIL Factor XI deficient plasma</tradeName>
    <deviceName>HemosIL Factor XI deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020210</emdnCode>
    <emdnDescription>COAGULATION FACTOR XI</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020011300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:18.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08426950484745</udiDi>
    <basicUdiDi>84269504847459T</basicUdiDi>
    <tradeName>HemosIL Factor V deficient plasma</tradeName>
    <deviceName>HemosIL Factor V deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020204</emdnCode>
    <emdnDescription>COAGULATION FACTOR V</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020011500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:13.151Z</lastUpdated>
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    <udiDi>08426950484738</udiDi>
    <basicUdiDi>84269504847389W</basicUdiDi>
    <tradeName>HemosIL Factor II deficient plasma</tradeName>
    <deviceName>HemosIL Factor II deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020202</emdnCode>
    <emdnDescription>COAGULATION FACTOR II ( PROTHROMBIN )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020012200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:12.369Z</lastUpdated>
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    <udiDi>08426950479277</udiDi>
    <basicUdiDi>8426950479277A7</basicUdiDi>
    <tradeName>HemosIL Factor XII deficient plasma</tradeName>
    <deviceName>HemosIL Factor XII deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020211</emdnCode>
    <emdnDescription>COAGULATION FACTOR XII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020011200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:10.753Z</lastUpdated>
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    <udiDi>08426950478676</udiDi>
    <basicUdiDi>8426950478676AJ</basicUdiDi>
    <tradeName>HemosIL Fibrinogen-C</tradeName>
    <deviceName>HemosIL Fibrinogen-C</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020301100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:05:06.749Z</lastUpdated>
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    <udiDi>08426950358725</udiDi>
    <basicUdiDi>842695035872593</basicUdiDi>
    <tradeName>HemosIL Factor XIII Antigen</tradeName>
    <deviceName>HemosIL Factor XIII Antigen</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020201300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:04:16.271Z</lastUpdated>
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    <udiDi>08426950087618</udiDi>
    <basicUdiDi>84269500876188L</basicUdiDi>
    <tradeName>HemosIL Fibrinogen-C XL</tradeName>
    <deviceName>HemosIL Fibrinogen-C XL</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020003900</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:04:05.156Z</lastUpdated>
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    <udiDi>08426950078951</udiDi>
    <basicUdiDi>84269500789518V</basicUdiDi>
    <tradeName>HemosIL von Willebrand Factor Activity</tradeName>
    <deviceName>HemosIL von Willebrand Factor Activity</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020217</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND ACTIVITY / RISTOCETIN COFACTOR ACTIVITY (RCO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020004700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:52.245Z</lastUpdated>
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    <udiDi>08426950041177</udiDi>
    <basicUdiDi>84269500411775M</basicUdiDi>
    <tradeName>HemosIL von Willebrand Factor Antigen</tradeName>
    <deviceName>HemosIL von Willebrand Factor Antigen</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020002300</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:16.977Z</lastUpdated>
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