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    <manufacturerName>MEDICAL &amp; BIOLOGICAL LABORATORIES CO., LTD.</manufacturerName>
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    <tradeName>Coagulation Control</tradeName>
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    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <tradeName>Factor XIII Calibrator</tradeName>
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    <tradeName>Factor XIII</tradeName>
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    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
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    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-205</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:32:55.374Z</lastUpdated>
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    <tradeName>Berichrom F XIII</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_Ber_FXIII</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>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873897</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:01.810Z</lastUpdated>
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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>
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    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K135C-10M</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
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    <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>
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    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-106C</reference>
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    <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>
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    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-105</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
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    <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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    <basicUdiDi>0405686900903VN</basicUdiDi>
    <tradeName>Berichrom F XIII</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>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446652</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T23:24:16.633Z</lastUpdated>
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