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    <tradeName>INNOVANCE VWF Ac</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_INN_VWF_Ac</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>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874049</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:31.368Z</lastUpdated>
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    <udiDi>00630414321592</udiDi>
    <basicUdiDi>0405686900905VS</basicUdiDi>
    <tradeName>Berichrom a2-Antiplasmin</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT_Ber_a2-Antipl</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020501</emdnCode>
    <emdnDescription>A2-ANTIPLASMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:29.265Z</lastUpdated>
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    <udiDi>00630414321561</udiDi>
    <basicUdiDi>0405686900968WJ</basicUdiDi>
    <tradeName>Protein S Ac</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_Prot_S_Ac</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>W0103020608</emdnCode>
    <emdnDescription>PROTEIN S ACTIVITY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:28.456Z</lastUpdated>
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    <udiDi>00630414320496</udiDi>
    <basicUdiDi>0405686900864W5</basicUdiDi>
    <tradeName>Dade Owren's Veronal Buffer</tradeName>
    <deviceName>IVDR_27_MAR EB_A_REAG_OVB</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020903</emdnCode>
    <emdnDescription>BUFFERS (HAEMOSTASIS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:24.452Z</lastUpdated>
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    <udiDi>00630414640518</udiDi>
    <basicUdiDi>0405686900175V7</basicUdiDi>
    <tradeName>INNOVANCE D-Dimer Controls</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_INN_D-Di_Con</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>W0103020799</emdnCode>
    <emdnDescription>HAEMOSTASIS CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873854</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:49.151Z</lastUpdated>
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  <row>
    <udiDi>00630414640495</udiDi>
    <basicUdiDi>0405686900192V7</basicUdiDi>
    <tradeName>PT Multi-Calibrator</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_KIT_PT-Multi_Cal</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>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873847</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:48.352Z</lastUpdated>
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    <udiDi>00630414640396</udiDi>
    <basicUdiDi>0405686900171UX</basicUdiDi>
    <tradeName>Dade Hepzyme</tradeName>
    <deviceName>IVDR_27_MAR EB_A_PROF_REAG_Hepzyme</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030299</emdnCode>
    <emdnDescription>HAEMOSTASIS REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873841</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:44.348Z</lastUpdated>
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    <udiDi>00630414640228</udiDi>
    <basicUdiDi>0405686900168VA</basicUdiDi>
    <tradeName>Dade Ci-Trol 1</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_Ci-Trol 1</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873821</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:44.286Z</lastUpdated>
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    <udiDi>00630414640136</udiDi>
    <basicUdiDi>0405686900172UZ</basicUdiDi>
    <tradeName>Dade Innovin</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_Innovin</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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873825</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:43.450Z</lastUpdated>
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    <udiDi>00630414639796</udiDi>
    <basicUdiDi>0405686900173V3</basicUdiDi>
    <tradeName>INNOVANCE Antithrombin</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_KIT_INN_AT</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>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873911</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:43.446Z</lastUpdated>
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  <row>
    <udiDi>00630414639666</udiDi>
    <basicUdiDi>0405686900176V9</basicUdiDi>
    <tradeName>INNOVANCE D-Dimer Sample Diluent</tradeName>
    <deviceName>IVDR_27_MAR EB_A_PROF_REAG_NN_D-Di_Sam_Dil</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:38.097Z</lastUpdated>
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  <row>
    <udiDi>00630414639369</udiDi>
    <basicUdiDi>0405686900194VB</basicUdiDi>
    <tradeName>Thromborel S</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_Thr_S</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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873886</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:37.171Z</lastUpdated>
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  <row>
    <udiDi>00630414635309</udiDi>
    <basicUdiDi>0405686900191V5</basicUdiDi>
    <tradeName>Pathromtin SL</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_Pathr_SL</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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873816</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:36.488Z</lastUpdated>
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    <udiDi>00630414627892</udiDi>
    <basicUdiDi>0405686900174V5</basicUdiDi>
    <tradeName>INNOVANCE D-Dimer</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_KIT_INN_D-Di</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>W0103020503</emdnCode>
    <emdnDescription>D-DIMER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873785</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:35.555Z</lastUpdated>
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    <udiDi>00630414321646</udiDi>
    <basicUdiDi>0405686900193V9</basicUdiDi>
    <tradeName>Standard Human Plasma</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_REAG_SHP</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>W0103020701</emdnCode>
    <emdnDescription>CALIBRATION PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10874051</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:29.935Z</lastUpdated>
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    <udiDi>00630414321578</udiDi>
    <basicUdiDi>0405686900140UL</basicUdiDi>
    <tradeName>Berichrom Antithrombin III (A)</tradeName>
    <deviceName>IVDR_27_MAR EB_C_PROF_KIT_Ber_ATIII</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>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446672</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:02:29.140Z</lastUpdated>
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    <udiDi>00195226001204</udiDi>
    <basicUdiDi>0195226001204PZ</basicUdiDi>
    <tradeName>HemosIL CL HIT-IgG(PF4-H)</tradeName>
    <deviceName>HemosIL CL HIT-IgG(PF4-H)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020402</emdnCode>
    <emdnDescription>PLATELET FACTOR 4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0029706200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:05:32.795Z</lastUpdated>
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    <udiDi>00195226000061</udiDi>
    <basicUdiDi>0195226000061PU</basicUdiDi>
    <tradeName>HemosIL Liquid Antithrombin</tradeName>
    <deviceName>HemosIL Liquid Antithrombin</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020602</emdnCode>
    <emdnDescription>ANTITHROMBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020300440</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:03:56.168Z</lastUpdated>
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    <udiDi>00195226000009</udiDi>
    <basicUdiDi>0195226000009PS</basicUdiDi>
    <tradeName>HemosIL Chromogenic Factor IX</tradeName>
    <deviceName>HemosIL Chromogenic Factor IX</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>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020001900</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:03:34.186Z</lastUpdated>
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    <udiDi>00842768030864</udiDi>
    <basicUdiDi>0405686900194VB</basicUdiDi>
    <tradeName>Thromborel S</tradeName>
    <deviceName></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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10484202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:10.684Z</lastUpdated>
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