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    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <udiDi>D-0320515401W2</udiDi>
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    <deviceName>PIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
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    <tradeName>HemosIL AcuStar ADAMTS13 Activity</tradeName>
    <deviceName>HemosIL AcuStar ADAMTS13 Activity</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <emdnDescription>ADAMTS13 (ACTIVITY, AG, AB, INHIBITOR) SPECIFIC VON WILLEBRAND FACTOR (VWF) - CLEAVING PROTEASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009802048</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:11:37.064Z</lastUpdated>
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    <udiDi>06978465236101</udiDi>
    <basicUdiDi>697846523OtherB01YN</basicUdiDi>
    <tradeName>Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:08.123Z</lastUpdated>
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    <udiDi>03607450003222</udiDi>
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    <tradeName>STA® - Liquid Anti-Xa 8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020309</emdnCode>
    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
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    <tradeName>HemosIL Liquid Anti-Xa</tradeName>
    <deviceName>HemosIL Liquid Anti-Xa</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
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    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
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    <reference>00020302601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:26.437Z</lastUpdated>
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    <tradeName>HemosIL Direct Thrombin Inhibitor Assay</tradeName>
    <deviceName>HemosIL Direct Thrombin Inhibitor Assay</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>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020310</emdnCode>
    <emdnDescription>ANTI IIA ACTIVITY FOT DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020302800</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:25:25.214Z</lastUpdated>
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    <tradeName>HemosIL Heparin</tradeName>
    <deviceName>HemosIL Heparin</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020009400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-30T12:23:02.334Z</lastUpdated>
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    <udiDi>06954414798739</udiDi>
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    <tradeName>MAGICL PIC (CLIA)</tradeName>
    <deviceName>MAGICL PIC (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:34:26.525Z</lastUpdated>
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    <tradeName>MAGICL TAT (CLIA)</tradeName>
    <deviceName>MAGICL TAT (CLIA)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-28T15:34:25.336Z</lastUpdated>
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    <basicUdiDi>B-06942028501685</basicUdiDi>
    <tradeName>PIC Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>PIC Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>SPECIAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DG0201</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:04.864Z</lastUpdated>
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    <tradeName>Thrombin-Antithrombin Ⅲ complex(TAT) Assay Kit(Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Thrombin-Antithrombin Ⅲ complex(TAT) Assay Kit(Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DG0101</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-26T00:16:01.277Z</lastUpdated>
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    <tradeName>INNOVANCE Anti-Xa</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>STANDARD HEPARIN</emdnDescription>
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    <reference>10873942</reference>
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    <tradeName>Anti-Xa Testing Kit(Chromogenic Assay)</tradeName>
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    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
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    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
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    <reference>NX-0029-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Anti-Xa Testing Kit(Chromogenic Assay)</tradeName>
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    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <tradeName>Anti-Xa Testing Kit(Chromogenic Assay)</tradeName>
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    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
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    <tradeName>Anti-Xa Testing Kit(Chromogenic Assay)</tradeName>
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    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
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    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0029-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>INNOVANCE Heparin</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873448</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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