<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08699343603881</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS12510-T</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:42:44.597Z</lastUpdated>
  </row>
</eudamedExport>