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    <tradeName>D-Dimer Fast Test Kit (Immunofluorescence Assay)</tradeName>
    <deviceName>D-Dimer Fast Test Kit (Immunofluorescence Assay)</deviceName>
    <manufacturerName>Getein Biotech, Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000017986</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:48:35.217Z</lastUpdated>
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    <tradeName>Antiserum to Human Plasminogen</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_AS_Plasm</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
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    <emdnDescription>PLASMINOGEN</emdnDescription>
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    <tradeName>Antiserum to Human Antithrombin III</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG _AS_ATIII</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
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    <emdnDescription>ANTITHROMBIN</emdnDescription>
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    <tradeName>Antiserum to Human Fibrinogen</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
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    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873654</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:43:12.241Z</lastUpdated>
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    <udiDi>18430155011153</udiDi>
    <basicUdiDi>B-18430155011153</basicUdiDi>
    <tradeName>CALIBRADOR DE COAGULACIÓN</tradeName>
    <deviceName>CALIBRADOR DE COAGULACIÓN</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>990945</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:19.736Z</lastUpdated>
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    <udiDi>18430155003929</udiDi>
    <basicUdiDi>B-18430155003929</basicUdiDi>
    <tradeName>CONTROLES DE COAGULACIÓN</tradeName>
    <deviceName>CONTROLES DE COAGULACIÓN</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>992550</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:18.042Z</lastUpdated>
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    <udiDi>09120036864467</udiDi>
    <basicUdiDi>B-09120036864467</basicUdiDi>
    <tradeName>09120036864467</tradeName>
    <deviceName>APIX CalSet</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09925074190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <basicUdiDi>B-09120036864443</basicUdiDi>
    <tradeName>09120036864443</tradeName>
    <deviceName>EDOX ControlSet</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:12.434Z</lastUpdated>
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    <udiDi>09120036864436</udiDi>
    <basicUdiDi>B-09120036864436</basicUdiDi>
    <tradeName>09120036864436</tradeName>
    <deviceName>APIX ControlSet</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09925180190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:11.808Z</lastUpdated>
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    <udiDi>09120036864450</udiDi>
    <basicUdiDi>B-09120036864450</basicUdiDi>
    <tradeName>09120036864450</tradeName>
    <deviceName>RIVA CalSet</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09925066190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:10.042Z</lastUpdated>
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    <udiDi>09120036864429</udiDi>
    <basicUdiDi>B-09120036864429</basicUdiDi>
    <tradeName>09120036864429</tradeName>
    <deviceName>RIVA ControlSet</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09925163190</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:36:07.761Z</lastUpdated>
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    <udiDi>09120036864313</udiDi>
    <basicUdiDi>B-09120036864313</basicUdiDi>
    <tradeName>09120036864313</tradeName>
    <deviceName>Technochrom DTI</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020310</emdnCode>
    <emdnDescription>ANTI IIA ACTIVITY FOT DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5347000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:35:50.757Z</lastUpdated>
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    <udiDi>09120036864221</udiDi>
    <basicUdiDi>B-09120036864221</basicUdiDi>
    <tradeName>09120036864221</tradeName>
    <deviceName>Technoview allXa CON</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5090310</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:35:49.960Z</lastUpdated>
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    <udiDi>93593990003774</udiDi>
    <basicUdiDi>9359399HX9904-508G</basicUdiDi>
    <tradeName>DOAC-Stop</tradeName>
    <deviceName>DOAC-Stop</deviceName>
    <manufacturerName>Cellabs Pty Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030640</manufacturerSrn>
    <authorisedRepresentativeName>WMDE B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002062</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020699</emdnCode>
    <emdnDescription>COAGULATION INHIBITORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HX9904-50</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:55:45.110Z</lastUpdated>
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    <udiDi>03607450011913</udiDi>
    <basicUdiDi>B-03607450011913</basicUdiDi>
    <tradeName>STA® - VWF:RCo</tradeName>
    <deviceName>STA® - VWF:RCo</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND ACTIVITY / RISTOCETIN COFACTOR ACTIVITY (RCO)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01191</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:47:07.697Z</lastUpdated>
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    <tradeName>F.S. Test Unit</tradeName>
    <deviceName>F.S. Test Unit</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
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    <emdnDescription>FIBRINOGEN DEGRADATION PRODUCTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>F.S. Test</tradeName>
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    <manufacturerName>Diagnostica Stago</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:47:01.814Z</lastUpdated>
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    <tradeName>D-Di Test®</tradeName>
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    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
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    <emdnDescription>D-DIMER</emdnDescription>
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    <tradeName>sthemO Owren PT</tradeName>
    <deviceName>PT Owren</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
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    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:44:29.405Z</lastUpdated>
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    <deviceName>D-Dimer Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>D-DIMER - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BF-S065</reference>
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    <lastUpdated>2026-07-17T01:49:31.996Z</lastUpdated>
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