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<eudamedExport entity="devices">
  <row>
    <udiDi>D-FAC-VIII-P5301-01097</udiDi>
    <basicUdiDi>B-FAC-VIII-P5301-01097</basicUdiDi>
    <tradeName>TEClot Factor VIII Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5301-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:34.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-VII-P5201-0107B</udiDi>
    <basicUdiDi>B-FAC-VII-P5201-0107B</basicUdiDi>
    <tradeName>TEClot Factor VII Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020205</emdnCode>
    <emdnDescription>COAGULATION FACTOR VII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5201-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:32.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-V-P5101-010AN</udiDi>
    <basicUdiDi>B-FAC-V-P5101-010AN</basicUdiDi>
    <tradeName>TEClot Factor V Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020204</emdnCode>
    <emdnDescription>COAGULATION FACTOR V</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5101-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:29.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-IX-P5401-0106C</udiDi>
    <basicUdiDi>B-FAC-IX-P5401-0106C</basicUdiDi>
    <tradeName>TEClot Factor IX Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5401-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:28.107Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FAC-II-P5001-010ML</udiDi>
    <basicUdiDi>B-FAC-II-P5001-010ML</basicUdiDi>
    <tradeName>TEClot Factor II Deficient Plasma</tradeName>
    <deviceName>FAC</deviceName>
    <manufacturerName>TECO Medical Instruments, Production + Trading GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000022642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020202</emdnCode>
    <emdnDescription>COAGULATION FACTOR II ( PROTHROMBIN )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P5001-010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:16:27.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21130047T</udiDi>
    <basicUdiDi>B-EBL21130047T</basicUdiDi>
    <tradeName>D-EBL21130047T</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2113004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:23:03.358Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21120047L</udiDi>
    <basicUdiDi>B-EBL21120047L</basicUdiDi>
    <tradeName>D-EBL21120047L</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2112004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:43.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL21110047D</udiDi>
    <basicUdiDi>B-EBL21110047D</basicUdiDi>
    <tradeName>D-EBL21110047D</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2111004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:36.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-EBL211000476</udiDi>
    <basicUdiDi>B-EBL211000476</basicUdiDi>
    <tradeName>D-EBL211000476</tradeName>
    <deviceName>Fibrinogen (Fib)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EBL2110004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:22:30.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350060320202</udiDi>
    <basicUdiDi>B-27350060320202</basicUdiDi>
    <tradeName>MRX Green vWF Antigen</tradeName>
    <deviceName>Green vWF Antigen</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5052</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:14.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350060320141</udiDi>
    <basicUdiDi>B-27350060320141</basicUdiDi>
    <tradeName>MRX Fib Clauss</tradeName>
    <deviceName>Fib Clauss</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K5031</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-11T13:17:09.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-150H60TSC3Q</udiDi>
    <basicUdiDi>B-150H60TSC3Q</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150H60TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:38:09.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-150H200TSCHX</udiDi>
    <basicUdiDi>B-150H200TSCHX</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150H200TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:38:05.320Z</lastUpdated>
  </row>
  <row>
    <udiDi>15065026245066</udiDi>
    <basicUdiDi>B-15065026245066</basicUdiDi>
    <tradeName>TruHemo</tradeName>
    <deviceName>FIB Test</deviceName>
    <manufacturerName>BioFynder Limited</manufacturerName>
    <manufacturerSrn>UK-MF-000047512</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TH10004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:37:08.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007456</udiDi>
    <basicUdiDi>B-13607450007456</basicUdiDi>
    <tradeName>STA® - Deficient II</tradeName>
    <deviceName>STA® - Deficient II</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020202</emdnCode>
    <emdnDescription>COAGULATION FACTOR II ( PROTHROMBIN )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00745</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:15.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007432</udiDi>
    <basicUdiDi>B-13607450007432</basicUdiDi>
    <tradeName>STA® - Deficient VII</tradeName>
    <deviceName>STA® - Deficient VII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020205</emdnCode>
    <emdnDescription>COAGULATION FACTOR VII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00743</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:11.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450007401</udiDi>
    <basicUdiDi>B-13607450007401</basicUdiDi>
    <tradeName>STA® - ImmunoDef II</tradeName>
    <deviceName>STA® - ImmunoDef II</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020202</emdnCode>
    <emdnDescription>COAGULATION FACTOR II ( PROTHROMBIN )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00740</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:10.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>13607450003151</udiDi>
    <basicUdiDi>B-13607450003151</basicUdiDi>
    <tradeName>STA® - ImmunoDef XII</tradeName>
    <deviceName>STA® - ImmunoDef XII</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020211</emdnCode>
    <emdnDescription>COAGULATION FACTOR XII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00315</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:50:03.885Z</lastUpdated>
  </row>
  <row>
    <udiDi>10859394006160</udiDi>
    <basicUdiDi>B-10859394006160</basicUdiDi>
    <tradeName>NoFact IX</tradeName>
    <deviceName>NoFact IX</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020208</emdnCode>
    <emdnDescription>COAGULATION FACTOR IX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:06.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>10859394006153</udiDi>
    <basicUdiDi>B-10859394006153</basicUdiDi>
    <tradeName>NoFact VIII</tradeName>
    <deviceName>NoFact VIII</deviceName>
    <manufacturerName>r2 Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000020735</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>68-201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:43:05.268Z</lastUpdated>
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