<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03607450009491</udiDi>
    <basicUdiDi>B-03607450009491</basicUdiDi>
    <tradeName>Asserachrom® PAI-1</tradeName>
    <deviceName>Asserachrom® PAI-1</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00949</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:51.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>03607450008074</udiDi>
    <basicUdiDi>B-03607450008074</basicUdiDi>
    <tradeName>Stachrom® PAI</tradeName>
    <deviceName>Stachrom® PAI</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00807</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:24.988Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320515704WP</udiDi>
    <basicUdiDi>B-0320515704WP</basicUdiDi>
    <tradeName>t-PAIC (eCLIA)</tradeName>
    <deviceName>t-PAIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515704</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:36.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320515703WM</udiDi>
    <basicUdiDi>B-0320515703WM</basicUdiDi>
    <tradeName>t-PAIC (eCLIA)</tradeName>
    <deviceName>t-PAIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515703</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:34.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320515702WK</udiDi>
    <basicUdiDi>B-0320515702WK</basicUdiDi>
    <tradeName>t-PAIC (eCLIA)</tradeName>
    <deviceName>t-PAIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515702</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:32.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0320515701WH</udiDi>
    <basicUdiDi>B-0320515701WH</basicUdiDi>
    <tradeName>t-PAIC (eCLIA)</tradeName>
    <deviceName>t-PAIC (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320515701</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:32:32.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236293</udiDi>
    <basicUdiDi>697846523OtherC03YX</basicUdiDi>
    <tradeName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:52.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236286</udiDi>
    <basicUdiDi>697846523OtherC03YX</basicUdiDi>
    <tradeName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:45.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236279</udiDi>
    <basicUdiDi>697846523OtherC03YX</basicUdiDi>
    <tradeName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:44.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236262</udiDi>
    <basicUdiDi>697846523OtherC03YX</basicUdiDi>
    <tradeName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:43.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236255</udiDi>
    <basicUdiDi>697846523OtherC03YX</basicUdiDi>
    <tradeName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Plasmin-α2-plasmin Inhibitor Complex Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020506</emdnCode>
    <emdnDescription>PLASMINOGEN ACTIVATOR-INHIBITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:42.019Z</lastUpdated>
  </row>
</eudamedExport>