<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>62230041031620</udiDi>
    <basicUdiDi>B-62230041031620</basicUdiDi>
    <tradeName>Recoplastin ISI 1.0 PT Reagent</tradeName>
    <deviceName>Recoplastin ISI 1.0 PT Reagent</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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>624 000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:26:34.615Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041031170</udiDi>
    <basicUdiDi>B-62230041031170</basicUdiDi>
    <tradeName>PT Reagent (SP-Normoplastin)</tradeName>
    <deviceName>PT Reagent (SP-Normoplastin)</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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>614 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:26:33.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041031002</udiDi>
    <basicUdiDi>B-62230041031002</basicUdiDi>
    <tradeName>PT Reagent (SP-Normoplastin)</tradeName>
    <deviceName>PT Reagent (SP-Normoplastin)</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>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>614 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:26:31.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041006734</udiDi>
    <basicUdiDi>B-62230041006734</basicUdiDi>
    <tradeName>APTT Reagent (SP-UNICELIN)</tradeName>
    <deviceName>APTT Reagent (SP-UNICELIN)</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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626 002</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:20:39.796Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041006666</udiDi>
    <basicUdiDi>B-62230041006666</basicUdiDi>
    <tradeName>APTT Reagent (SP-UNICELIN)</tradeName>
    <deviceName>APTT Reagent (SP-UNICELIN)</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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>626 001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:20:37.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155010545</udiDi>
    <basicUdiDi>B-18430155010545</basicUdiDi>
    <tradeName>PLASMASCANN® LIQUIDO</tradeName>
    <deviceName>PLASMASCANN®</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997059</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:41:19.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>18430155007903</udiDi>
    <basicUdiDi>B-18430155007903</basicUdiDi>
    <tradeName>PLASMASCANN® LIQUIDO</tradeName>
    <deviceName>PLASMASCANN®</deviceName>
    <manufacturerName>QUIMICA CLINICA APLICADA S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000001512</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>997054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:41:18.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976117451063</udiDi>
    <basicUdiDi>B-06976117451063</basicUdiDi>
    <tradeName>Prothrombin Time Assay Reagent (Coagulation Method)</tradeName>
    <deviceName>Prothrombin Time Assay Reagent (Coagulation Method)</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NX-0002-05</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:31:57.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>06947145553593</udiDi>
    <basicUdiDi>B-06947145553593</basicUdiDi>
    <tradeName>Hemolumi PT (Clotting Assay)</tradeName>
    <deviceName>PT (Clotting Assay)</deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020101</emdnCode>
    <emdnDescription>PROTHROMBIN TIME ( QUICK TEST )</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>133101001NSNM1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:55:37.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895312161</udiDi>
    <basicUdiDi>B-06936895312161</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): 0.5mL×1（521006）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:32:40.313Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303770</udiDi>
    <basicUdiDi>B-06936895303770</basicUdiDi>
    <tradeName>Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)</tradeName>
    <deviceName>Actived Partial Thromboplastin Time(APTT)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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma(abnormal):1.0mL×1（52106）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:59.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303763</udiDi>
    <basicUdiDi>B-06936895303763</basicUdiDi>
    <tradeName>Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)</tradeName>
    <deviceName>Actived Partial Thromboplastin Time(APTT)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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma(normal):1.0mL×1（521015）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:57.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303756</udiDi>
    <basicUdiDi>B-06936895303756</basicUdiDi>
    <tradeName>Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)</tradeName>
    <deviceName>Actived Partial Thromboplastin Time(APTT)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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma(abnormal):0.5mL×1（521014）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:57.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303749</udiDi>
    <basicUdiDi>B-06936895303749</basicUdiDi>
    <tradeName>Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)</tradeName>
    <deviceName>Actived Partial Thromboplastin Time(APTT)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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality control plasma(normal):0.5mL×1（521013）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:55.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303732</udiDi>
    <basicUdiDi>B-06936895303732</basicUdiDi>
    <tradeName>Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)</tradeName>
    <deviceName>Actived Partial Thromboplastin Time(APTT)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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Reagent:4mL×10,CaCl2:45mL×1（503004）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:53.011Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303725</udiDi>
    <basicUdiDi>B-06936895303725</basicUdiDi>
    <tradeName>Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation)</tradeName>
    <deviceName>Activated Partial Thromboplastin Time (APTT) 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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Reagent:2.5mL×10,CaCl2:30mL×1（502004）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:51.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303718</udiDi>
    <basicUdiDi>B-06936895303718</basicUdiDi>
    <tradeName>Activated Partial Thromboplastin Time (APTT) Test kit (Coagulation)</tradeName>
    <deviceName>Actived Partial Thromboplastin Time(APTT)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>W0103020102</emdnCode>
    <emdnDescription>ACTIVATED PARTIAL THROMBOPLASTIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Reagent:2mL×10,CaCl2:25mL×1（501004）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:50.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303701</udiDi>
    <basicUdiDi>B-06936895303701</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 (abnormal): 1.0mL×1（521012）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:48.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303695</udiDi>
    <basicUdiDi>B-06936895303695</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): 1.0mL×1（521011）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:46.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895303688</udiDi>
    <basicUdiDi>B-06936895303688</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 (abnormal): 0.5mL×1（521010）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T15:31:44.997Z</lastUpdated>
  </row>
</eudamedExport>