<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06936895303671</udiDi>
    <basicUdiDi>B-06936895303671</basicUdiDi>
    <tradeName>Prothrombin Time (PT) Test Kit (Coagulation)</tradeName>
    <deviceName>Prothrombin Time (PT) Test 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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (normal): 0.5mL×1（521009）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:44.195Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303664</udiDi>
    <basicUdiDi>B-06936895303664</basicUdiDi>
    <tradeName>Prothrombin Time (PT) Test Kit (Coagulation)</tradeName>
    <deviceName>Prothrombin Time (PT) Test 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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent:4mL×10,Reconstitution solution:45mL×1（503003）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:42.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303657</udiDi>
    <basicUdiDi>B-06936895303657</basicUdiDi>
    <tradeName>Prothrombin Time (PT) Test Kit (Coagulation)</tradeName>
    <deviceName>Prothrombin Time (PT) 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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent:2.5mL×10,Reconstitution solution:30mL×1（502003）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:40.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303640</udiDi>
    <basicUdiDi>B-06936895303640</basicUdiDi>
    <tradeName>Prothrombin Time (PT) Test Kit (Coagulation)</tradeName>
    <deviceName>Prothrombin Time (PT) 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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent:2mL×10,Reconstitution solution:25mL×1（501003）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:38.586Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303633</udiDi>
    <basicUdiDi>B-06936895303633</basicUdiDi>
    <tradeName>Thrombin Time (TT) Test Kit (Coagulation)</tradeName>
    <deviceName>Thrombin Time (TT) Test 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (abnormal): 1.0mL×1（521008）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:37.799Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303626</udiDi>
    <basicUdiDi>B-06936895303626</basicUdiDi>
    <tradeName>Thrombin Time (TT) Test Kit (Coagulation)</tradeName>
    <deviceName>Thrombin Time (TT) Test 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (normal): 1.0mL×1（521007）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:36.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303619</udiDi>
    <basicUdiDi>B-06936895303619</basicUdiDi>
    <tradeName>Thrombin Time (TT) Test Kit (Coagulation)</tradeName>
    <deviceName>Thrombin Time (TT) Test 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma (normal): 0.5mL×1（521005）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:33.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303602</udiDi>
    <basicUdiDi>B-06936895303602</basicUdiDi>
    <tradeName>Thrombin Time (TT) Test Kit (Coagulation)</tradeName>
    <deviceName>Thrombin Time (TT) 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent 4mL×10, Reconstitution solution 45mL×1（503002）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:32.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303589</udiDi>
    <basicUdiDi>B-06936895303589</basicUdiDi>
    <tradeName>Thrombin Time (TT) Test Kit (Coagulation)</tradeName>
    <deviceName>Thrombin Time (TT) 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent 2mL×10, Reconstitution solution 25mL×1（501002）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:31.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303596</udiDi>
    <basicUdiDi>B-06936895303596</basicUdiDi>
    <tradeName>Thrombin Time (TT) Test Kit (Coagulation)</tradeName>
    <deviceName>Thrombin Time (TT) 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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Freeze-dried：Reagent 2.5mL×10, Reconstitution solution 30mL×1（502002）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:29.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>27350060320578</udiDi>
    <basicUdiDi>7350060320036Q</basicUdiDi>
    <tradeName>STA® - Owren PT</tradeName>
    <deviceName>PT Owren</deviceName>
    <manufacturerName>Nordic Biomarker AB</manufacturerName>
    <manufacturerSrn>SE-MF-000022201</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020199</emdnCode>
    <emdnDescription>GENERAL COAGULATION TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01675</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:45:02.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414639635</udiDi>
    <basicUdiDi>0405686900990WB</basicUdiDi>
    <tradeName>Test Thrombin Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT _Test_Thromb</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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873894</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:24:40.526Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768013102</udiDi>
    <basicUdiDi>0405686900900VG</basicUdiDi>
    <tradeName>BC Thrombin Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_C_KIT_BC_Thromb</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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446636</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:20:36.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414640211</udiDi>
    <basicUdiDi>0405686900972W9</basicUdiDi>
    <tradeName>Thromboclotin</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_Thromboclotin</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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873820</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:28.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414639611</udiDi>
    <basicUdiDi>0405686900899WQ</basicUdiDi>
    <tradeName>Batroxobin Reagent</tradeName>
    <deviceName>IVDR_27_MAR EB_C_REAG_Batrox</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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10873889</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:15:01.016Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>00842768003783</udiDi>
    <basicUdiDi>0405686900172UZ</basicUdiDi>
    <tradeName>Dade Innovin</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>10445704</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:11.686Z</lastUpdated>
  </row>
</eudamedExport>