<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08858788502023</udiDi>
    <basicUdiDi>B-08858788502023</basicUdiDi>
    <tradeName>HYDRA Aortic Valve</tradeName>
    <deviceName>Hydra aortic valve</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301030204</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA30</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:37:22.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>08858788502016</udiDi>
    <basicUdiDi>B-08858788502016</basicUdiDi>
    <tradeName>HYDRA Aortic Valve</tradeName>
    <deviceName>Hydra aortic valve</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301030204</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA26</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:37:05.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>08858788502009</udiDi>
    <basicUdiDi>B-08858788502009</basicUdiDi>
    <tradeName>HYDRA Aortic Valve</tradeName>
    <deviceName>Hydra aortic valve</deviceName>
    <manufacturerName>Vascular Innovations Co. Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000028144</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P070301030204</emdnCode>
    <emdnDescription>STENTED BIOLOGICAL TRICUSPID VALVES FOR PERCUTANEOUS IMPLANT - NON-VALVE TISSUE OF ANIMAL ORIGIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HYDRA22</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-04T11:37:03.589Z</lastUpdated>
  </row>
</eudamedExport>