<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06925912736288</udiDi>
    <basicUdiDi>692591270290HN</basicUdiDi>
    <tradeName>iFlash-t-PAIC</tradeName>
    <deviceName>iFlash-t-PAIC</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:36:57.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>06925912736349</udiDi>
    <basicUdiDi>692591270290HN</basicUdiDi>
    <tradeName>iFlash-t-PAIC</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86122-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:38:12.082Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978945081658</udiDi>
    <basicUdiDi>B-06978945081658</basicUdiDi>
    <tradeName>Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）</tradeName>
    <deviceName>Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1411B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:32.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978945081641</udiDi>
    <basicUdiDi>B-06978945081641</basicUdiDi>
    <tradeName>Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）</tradeName>
    <deviceName>Tissue Plasminogen Activator Inhibitor 1 Complex Kit（CLIA）</deviceName>
    <manufacturerName>Jiangxi Medicalsystem Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000050651</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA1411A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:58:30.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236248</udiDi>
    <basicUdiDi>697846523OtherC02YV</basicUdiDi>
    <tradeName>Fibrin Degradation Product Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Fibrin Degradation Product 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>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:36.057Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236231</udiDi>
    <basicUdiDi>697846523OtherC02YV</basicUdiDi>
    <tradeName>Fibrin Degradation Product Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Fibrin Degradation Product 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>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:34.814Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236224</udiDi>
    <basicUdiDi>697846523OtherC02YV</basicUdiDi>
    <tradeName>Fibrin Degradation Product Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Fibrin Degradation Product 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>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:33.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236217</udiDi>
    <basicUdiDi>697846523OtherC02YV</basicUdiDi>
    <tradeName>Fibrin Degradation Product Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Fibrin Degradation Product 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>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:32.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236200</udiDi>
    <basicUdiDi>697846523OtherC02YV</basicUdiDi>
    <tradeName>Fibrin Degradation Product Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Fibrin Degradation Product 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>W0103020599</emdnCode>
    <emdnDescription>FIBRINOLYSIS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:25.212Z</lastUpdated>
  </row>
</eudamedExport>