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<eudamedExport entity="devices">
  <row>
    <udiDi>62230041020976</udiDi>
    <basicUdiDi>B-62230041020976</basicUdiDi>
    <tradeName>Fibrinogen-LS Clauss Clotting Time Method</tradeName>
    <deviceName>Fibrinogen-LS Clauss Clotting Time Method</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>631 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:23:58.054Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041020808</udiDi>
    <basicUdiDi>B-62230041020808</basicUdiDi>
    <tradeName>Fibrinogen-LS Clauss Clotting Time Method</tradeName>
    <deviceName>Fibrinogen-LS Clauss Clotting Time Method</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>631 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:23:56.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041020730</udiDi>
    <basicUdiDi>B-62230041020730</basicUdiDi>
    <tradeName>FIBRINOGEN</tradeName>
    <deviceName>FIBRINOGEN</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>590 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:23:54.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303565</udiDi>
    <basicUdiDi>B-06936895303565</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (normal): 1.0mL×1（521003）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:27.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303572</udiDi>
    <basicUdiDi>B-06936895303572</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (abnormal): 1.0mL×1（521004）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:25.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303558</udiDi>
    <basicUdiDi>B-06936895303558</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (abnormal): 0.5mL×1(521002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:12.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303541</udiDi>
    <basicUdiDi>B-06936895303541</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (normal): 0.5mL×1（521001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:10.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303534</udiDi>
    <basicUdiDi>B-06936895303534</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibration plasma:1.0mL×1（511002）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:08.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303510</udiDi>
    <basicUdiDi>B-06936895303510</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:06.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303527</udiDi>
    <basicUdiDi>B-06936895303527</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibration plasma: 0.5mL×1（511001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:05.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303503</udiDi>
    <basicUdiDi>B-06936895303503</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent:2.5mL×5, Diluent:50mL×2（502001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:04.341Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303497</udiDi>
    <basicUdiDi>B-06936895303497</basicUdiDi>
    <tradeName>Fibrinogen (FIB) Test Kit (Coagulation)</tradeName>
    <deviceName>Fibrinogen (FIB) Assay Kit (Coagulation)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:01.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426021013</udiDi>
    <basicUdiDi>B-00816426021013</basicUdiDi>
    <tradeName>Coagulation Control</tradeName>
    <deviceName>Coagulation Control</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K204C-10M</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:32:59.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020764</udiDi>
    <basicUdiDi>B-00816426020764</basicUdiDi>
    <tradeName>Factor XIII Calibrator</tradeName>
    <deviceName>Factor XIII Calibrator</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-206C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:32:56.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020535</udiDi>
    <basicUdiDi>B-00816426020535</basicUdiDi>
    <tradeName>Factor XIII</tradeName>
    <deviceName>Factor XIII</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020213</emdnCode>
    <emdnDescription>COAGULATION FACTOR XIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-205</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:32:55.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414640433</udiDi>
    <basicUdiDi>0405686900991WD</basicUdiDi>
    <tradeName>vWF Ag</tradeName>
    <deviceName>IVDR_27_MAR EB_B_KIT _vWF_Ag</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>W0103020215</emdnCode>
    <emdnDescription>COAGULATION FACTOR VON WILLEBRAND (AG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873845</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:45.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768009945</udiDi>
    <basicUdiDi>0405686900943W2</basicUdiDi>
    <tradeName>N Antiserum to Human Fibrinogen</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_N_AS_FIB</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>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446313</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:06.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414640389</udiDi>
    <basicUdiDi>0405686900866W9</basicUdiDi>
    <tradeName>Factor VIII Chromogenic Assay</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_FVIII_Chrom</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>W0103020207</emdnCode>
    <emdnDescription>COAGULATION FACTOR VIII</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873840</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:38.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414640266</udiDi>
    <basicUdiDi>0405686900865W7</basicUdiDi>
    <tradeName>Dade Thrombin Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_Thromb_Reag</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>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873837</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:38.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414640143</udiDi>
    <basicUdiDi>0405686900863W3</basicUdiDi>
    <tradeName>Dade Fibrinogen Determination Reagents</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_Fib_Determ_Reag</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>W0103020201</emdnCode>
    <emdnDescription>FIBRINOGEN ASSAYS (FACTOR I)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873835</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:10.622Z</lastUpdated>
  </row>
</eudamedExport>