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    <manufacturerName>Blackhills Diagnostic Resources S.L.U.</manufacturerName>
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    <tradeName>Genvinset® FIIFV multiplex 24 test</tradeName>
    <deviceName>Genvinset® FIIFV multiplex</deviceName>
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    <tradeName>HemosIL Factor VIII deficient plasma</tradeName>
    <deviceName>HemosIL Factor VIII deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <reference>0020012800</reference>
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    <tradeName>HemosIL Factor VIII deficient plasma</tradeName>
    <deviceName>HemosIL Factor VIII deficient plasma</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <reference>0020011800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <tradeName>HemosIL Factor IX deficient plasma</tradeName>
    <deviceName>HemosIL Factor IX 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 C</riskClass>
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    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020011900</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:24:13.177Z</lastUpdated>
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    <udiDi>06903053025416</udiDi>
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    <tradeName>Fibrinogen (FIB) Assay Kit (Clotting Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-023623-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:56.396Z</lastUpdated>
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    <tradeName>Fibrinogen (FIB) Assay Kit (Clotting Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
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    <tradeName>Fibrinogen (FIB) Assay Kit (Clotting Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <basicUdiDi>69449040AB75000065V</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Assay Kit (Clotting Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-023626-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:56.345Z</lastUpdated>
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    <basicUdiDi>69449040AB75000065V</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Assay Kit (Clotting Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
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    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-023627-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T11:11:56.334Z</lastUpdated>
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    <basicUdiDi>0405686900866W9</basicUdiDi>
    <tradeName>Factor VIII Chromogenic Assay</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>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445729</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T01:40:52.900Z</lastUpdated>
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    <basicUdiDi>0405686900858WA</basicUdiDi>
    <tradeName>Coagulation Factor II Deficient Plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</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>10873878</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:52:12.017Z</lastUpdated>
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    <tradeName>Coagulation Factor II Deficient Plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874033</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:51:18.571Z</lastUpdated>
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    <tradeName>Coagulation Factor V Deficient Plasma</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874066</reference>
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    <lastUpdated>2026-06-26T19:51:03.820Z</lastUpdated>
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    <tradeName>Coagulation Factor IX Deficient Plasma</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-26T19:50:52.809Z</lastUpdated>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <lastUpdated>2026-06-26T19:50:52.793Z</lastUpdated>
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    <tradeName>Coagulation Factor VII Deficient Plasma</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Coagulation Factor X Deficient Plasma</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-26T19:50:50.980Z</lastUpdated>
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    <tradeName>Coagulation Factor IX Deficient Plasma</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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