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    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <tradeName>Soluplastin</tradeName>
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    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
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    <tradeName>Soluplastin</tradeName>
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    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
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    <tradeName>Soluplastin</tradeName>
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    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
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    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
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    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
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    <tradeName>Prothrombin Time</tradeName>
    <deviceName>Soluplastin</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <tradeName>Prothrombin Time plus</tradeName>
    <deviceName>Prothrombin Time plus</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
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    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
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    <tradeName>Prothrombin Time plus</tradeName>
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    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
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    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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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    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-CL1-PT-SC-48</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:47:01.306Z</lastUpdated>
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    <basicUdiDi>B-06978896413751</basicUdiDi>
    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-CL1-PT-SC-12</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:46:55.581Z</lastUpdated>
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    <basicUdiDi>B-06978896413744</basicUdiDi>
    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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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    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-CL1-PT-SC-06</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:46:54.781Z</lastUpdated>
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    <basicUdiDi>B-06978896413560</basicUdiDi>
    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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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    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:46:26.012Z</lastUpdated>
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    <basicUdiDi>B-06978896413553</basicUdiDi>
    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-CL1-PT-24</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:46:21.961Z</lastUpdated>
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    <basicUdiDi>B-06978896413546</basicUdiDi>
    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</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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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>PT CoaguDx Test Strip</tradeName>
    <deviceName>PT CoaguDx Test Strip</deviceName>
    <manufacturerName>WUHAN EASYDIAGNOSIS BIOMEDICINE CO., LTD.</manufacturerName>
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    <tradeName>Prothrombin Time Assay Reagent (Coagulation Method)</tradeName>
    <deviceName>Prothrombin Time Assay Reagent (Coagulation Method)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0002-07</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:28:40.955Z</lastUpdated>
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    <basicUdiDi>B-06976117451070</basicUdiDi>
    <tradeName>Prothrombin Time Assay Reagent (Coagulation Method)</tradeName>
    <deviceName>Prothrombin Time Assay Reagent (Coagulation Method)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Prothrombin Time Assay Reagent (Coagulation Method)</tradeName>
    <deviceName>Prothrombin Time Assay Reagent (Coagulation Method)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <lastUpdated>2026-07-06T21:28:36.168Z</lastUpdated>
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    <tradeName>Prothrombin Time Assay Reagent (Coagulation Method)</tradeName>
    <deviceName>Prothrombin Time Assay Reagent (Coagulation Method)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Prothrombin Time Assay Reagent (Coagulation Method)</tradeName>
    <deviceName>Prothrombin Time Assay Reagent (Coagulation Method)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-06T21:28:34.556Z</lastUpdated>
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