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<eudamedExport entity="devices">
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    <udiDi>62230182721374</udiDi>
    <basicUdiDi>B-62230182721374</basicUdiDi>
    <tradeName>PT Reagent ISI 1.5</tradeName>
    <deviceName>PT Reagent ISI 1.5</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</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>D-707 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:10.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182716974</udiDi>
    <basicUdiDi>B-62230182716974</basicUdiDi>
    <tradeName>PT Reagent ISI 1.5</tradeName>
    <deviceName>PT Reagent ISI 1.5</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</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>D-707 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:37:01.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230182716806</udiDi>
    <basicUdiDi>B-62230182716806</basicUdiDi>
    <tradeName>PT Reagent ISI 1.5</tradeName>
    <deviceName>PT Reagent ISI 1.5</deviceName>
    <manufacturerName>Kalians Corporation</manufacturerName>
    <manufacturerSrn>EG-MF-000050142</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>D-707 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:37:00.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041031934</udiDi>
    <basicUdiDi>B-62230041031934</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>624 003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:26:39.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041031866</udiDi>
    <basicUdiDi>B-62230041031866</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>624 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:26:38.475Z</lastUpdated>
  </row>
  <row>
    <udiDi>62230041031798</udiDi>
    <basicUdiDi>B-62230041031798</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>624 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:26:36.535Z</lastUpdated>
  </row>
  <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>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>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>
  <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>
</eudamedExport>