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    <deviceName>iFlash-PIC</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>C86123</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:56.245Z</lastUpdated>
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    <deviceName>iFlash-TAT</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
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    <lastUpdated>2026-07-31T15:36:55.470Z</lastUpdated>
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    <udiDi>03607450012354</udiDi>
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    <tradeName>sthemO Anti-Xa M</tradeName>
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    <manufacturerName>Diagnostica Stago</manufacturerName>
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    <emdnDescription>LOW MOLECULAR WEIGHT HEPARIN</emdnDescription>
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    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103020310</emdnCode>
    <emdnDescription>ANTI IIA ACTIVITY FOT DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00992</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:10:38.105Z</lastUpdated>
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    <udiDi>03607450005431</udiDi>
    <basicUdiDi>360745099FM0001Z3</basicUdiDi>
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    <deviceName>STA® - Liatest® FM</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020301</emdnCode>
    <emdnDescription>FIBRIN SENSITIVITY MONOMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00543</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:10:02.029Z</lastUpdated>
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    <udiDi>03607450003116</udiDi>
    <basicUdiDi>36074509AXA000183</basicUdiDi>
    <tradeName>STA® - Liquid Anti-Xa 4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020309</emdnCode>
    <emdnDescription>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00311</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:09:54.825Z</lastUpdated>
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    <udiDi>09120036862715</udiDi>
    <basicUdiDi>B-09120036862715</basicUdiDi>
    <tradeName>09120036862715</tradeName>
    <deviceName>TECHNOCHROM anti-Xa</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>ANTI XA ACTIVITY FOR HEPARIN AND DOAC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
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    <tradeName>09120036864313</tradeName>
    <deviceName>Technochrom DTI</deviceName>
    <manufacturerName>Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000024115</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103020310</emdnCode>
    <emdnDescription>ANTI IIA ACTIVITY FOT DOAC</emdnDescription>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:35:50.757Z</lastUpdated>
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    <udiDi>00630414240404</udiDi>
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    <tradeName>INNOVANCE Anti-Xa</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_INN_A-Xa</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>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873681</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:33:36.360Z</lastUpdated>
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    <udiDi>00842768013065</udiDi>
    <basicUdiDi>0405686900931VT</basicUdiDi>
    <tradeName>Enzygnost TAT micro</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_Enz_TAT_mic</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>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:38.440Z</lastUpdated>
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    <udiDi>00842768006760</udiDi>
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    <tradeName>Enzygnost F1+2 monoclonal</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_Enz_F1+2_mono</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>W0103020306</emdnCode>
    <emdnDescription>PROTHROMBIN FRAGMENT 1 + 2</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445978</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:19:09.572Z</lastUpdated>
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    <udiDi>00630414639925</udiDi>
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    <tradeName>INNOVANCE DTI Assay</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_INN_DTI</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>W0103020399</emdnCode>
    <emdnDescription>SPECIAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873922</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:10.345Z</lastUpdated>
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    <udiDi>00630414639802</udiDi>
    <basicUdiDi>0405686900871W2</basicUdiDi>
    <tradeName>INNOVANCE Heparin</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_INN_Hep</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>W0103020303</emdnCode>
    <emdnDescription>STANDARD HEPARIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873916</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:03.414Z</lastUpdated>
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    <udiDi>D-TM706-AEBL</udiDi>
    <basicUdiDi>B-TM706-AEBL</basicUdiDi>
    <tradeName>TM Thrombomodulin (CLIA)</tradeName>
    <deviceName>TM Thrombomodulin (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020399</emdnCode>
    <emdnDescription>SPECIAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM706-AE10Y, TM706-AE10N, TM706-AE20Y, TM706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:59:04.968Z</lastUpdated>
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    <udiDi>D-TAT706-AE6M</udiDi>
    <basicUdiDi>B-TAT706-AE6M</basicUdiDi>
    <tradeName>TAT Thrombin-Antithrombin III Complex (CLIA)</tradeName>
    <deviceName>TAT Thrombin-Antithrombin III Complex (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
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    <reference>TAT706-AE10Y, TAT706-AE10N, TAT706-AE20Y, TAT706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:54:47.244Z</lastUpdated>
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    <udiDi>D-PIC706-AEXD</udiDi>
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    <tradeName>PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)</tradeName>
    <deviceName>PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PIC706-AE10Y, PIC706-AE10N, PIC706-AE20Y, PIC706-AE20N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:45:14.467Z</lastUpdated>
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    <udiDi>00842768014482</udiDi>
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    <tradeName>INNOVANCE DTI Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103020399</emdnCode>
    <emdnDescription>SPECIAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873467</reference>
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    <tradeName>iStar-PIC</tradeName>
    <deviceName>iStar-PIC</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:13.044Z</lastUpdated>
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    <deviceName>iStar-PIC</deviceName>
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    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <emdnCode>W0103020305</emdnCode>
    <emdnDescription>PLASMIN - A2 - ANTIPLASMIN COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76111</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:10.717Z</lastUpdated>
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    <tradeName>iStar-TAT</tradeName>
    <deviceName>iStar-TAT</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</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>DC76109</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:05:08.421Z</lastUpdated>
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