<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06938820524403</udiDi>
    <basicUdiDi>69388205000000000000002ZN</basicUdiDi>
    <tradeName>06938820524403</tradeName>
    <deviceName>Balloon Inflation Device</deviceName>
    <manufacturerName>SCW Medicath Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019140</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R03020202</emdnCode>
    <emdnDescription>SELF-INFLATING VENTILATION BALLOONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42.04.30029</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:21:54.768Z</lastUpdated>
  </row>
</eudamedExport>