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    <tradeName>MRX FDP Clear High Control</tradeName>
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    <manufacturerName>Nordic Biomarker AB</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <tradeName>MRX FDP Clear Low Control</tradeName>
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    <manufacturerName>Nordic Biomarker AB</manufacturerName>
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    <tradeName>CoaguDx Quality Control</tradeName>
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    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
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    <tradeName>CoaguDx Quality Control</tradeName>
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    <tradeName>CoaguDx Quality Control</tradeName>
    <deviceName>CoaguDx Quality Control</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019908</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
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    <tradeName>CoaguDx Quality Control</tradeName>
    <deviceName>CoaguDx Quality Control</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
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    <udiDi>06974671101882</udiDi>
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    <tradeName>06974671101882</tradeName>
    <deviceName>D-Dimer Calibrator</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:10:13.768Z</lastUpdated>
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    <udiDi>06947145558727</udiDi>
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    <tradeName>Hemolumi D-Dimer Controls</tradeName>
    <deviceName>D-Dimer Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1602047153QLSN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:31:35.017Z</lastUpdated>
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    <udiDi>06947145558628</udiDi>
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    <tradeName>Hemolumi FDP Controls</tradeName>
    <deviceName>FDP Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:31:33.396Z</lastUpdated>
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    <udiDi>06947145558550</udiDi>
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    <tradeName>Hemolumi Coagulation Controls</tradeName>
    <deviceName>Coagulation Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1601040003SN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:31:30.991Z</lastUpdated>
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    <udiDi>06947145558543</udiDi>
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    <tradeName>Hemolumi Coagulation Controls</tradeName>
    <deviceName>Coagulation Controls</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:31:26.992Z</lastUpdated>
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    <udiDi>00859110005142</udiDi>
    <basicUdiDi>B-00859110005142</basicUdiDi>
    <tradeName>VALIDATE® FIBRINOGEN Test Set</tradeName>
    <deviceName>VALIDATE® FIBRINOGEN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>904se</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:39:44.761Z</lastUpdated>
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    <tradeName>VALIDATE® HEPARIN Test Set</tradeName>
    <deviceName>VALIDATE® HEPARIN Test Set</deviceName>
    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000029697</manufacturerSrn>
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    <tradeName>VALIDATE® FIBRINOGEN Test Set</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <tradeName>VALIDATE® FIBRINOGEN Test Set</tradeName>
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    <tradeName>VALIDATE® HEPARIN Test Set</tradeName>
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    <tradeName>VALIDATE® HEPARIN Test Set</tradeName>
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    <manufacturerName>LGC Clinical Diagnostics, Inc.</manufacturerName>
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    <deviceName>Thromboelastography Reagent Control</deviceName>
    <manufacturerName>MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.</manufacturerName>
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