<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978465237139</udiDi>
    <basicUdiDi>697846523ProteinC13RL</basicUdiDi>
    <tradeName>B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>B-type natriuretic peptide 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:43.241Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237122</udiDi>
    <basicUdiDi>697846523ProteinC13RL</basicUdiDi>
    <tradeName>B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>B-type natriuretic peptide 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:42.052Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237115</udiDi>
    <basicUdiDi>697846523ProteinC11RG</basicUdiDi>
    <tradeName>N-terminal pro B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>N-terminal pro B-type natriuretic peptide 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:36.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237108</udiDi>
    <basicUdiDi>697846523ProteinC11RG</basicUdiDi>
    <tradeName>N-terminal pro B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>N-terminal pro B-type natriuretic peptide 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:34.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237092</udiDi>
    <basicUdiDi>697846523ProteinC11RG</basicUdiDi>
    <tradeName>N-terminal pro B-type natriuretic peptide Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>N-terminal pro B-type natriuretic peptide 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>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:33.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237085</udiDi>
    <basicUdiDi>697846523ProteinC14RN</basicUdiDi>
    <tradeName>Myoglobin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Myoglobin 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:32.460Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237078</udiDi>
    <basicUdiDi>697846523ProteinC14RN</basicUdiDi>
    <tradeName>Myoglobin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Myoglobin 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:26.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237061</udiDi>
    <basicUdiDi>697846523ProteinC14RN</basicUdiDi>
    <tradeName>Myoglobin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Myoglobin 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>W01021304</emdnCode>
    <emdnDescription>MYOGLOBIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:25.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237054</udiDi>
    <basicUdiDi>697846523ProteinC10RE</basicUdiDi>
    <tradeName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:24.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237047</udiDi>
    <basicUdiDi>697846523ProteinC10RE</basicUdiDi>
    <tradeName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:22.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465237030</udiDi>
    <basicUdiDi>697846523ProteinC10RE</basicUdiDi>
    <tradeName>High Sensitive Cardiac Troponin I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>High Sensitive Cardiac Troponin I 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>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:16.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236491</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II 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>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:15.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236484</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II 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>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:14.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236477</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II 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>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:13.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236460</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II 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>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:06.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236453</udiDi>
    <basicUdiDi>697846523TumorC029X</basicUdiDi>
    <tradeName>Protein Induced by Vitamin K Absence or Antagonist-II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Protein Induced by Vitamin K Absence or Antagonist-II 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>W0102039017</emdnCode>
    <emdnDescription>PROTEIN INDUCED BY VITAMIN K ABSENCE OR ANTAGONIST-II (PIVKA-II)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:04.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236347</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:03.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236330</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:24:02.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236323</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×50 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:56.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236316</udiDi>
    <basicUdiDi>697846523OtherC04YZ</basicUdiDi>
    <tradeName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 Complex Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Tissue type plasminogen activator - plasminogen activator inhibitor 1 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>W0103020507</emdnCode>
    <emdnDescription>TISSUE PLASMINOGEN ACTIVATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T09:23:55.209Z</lastUpdated>
  </row>
</eudamedExport>