<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05061006350006</udiDi>
    <basicUdiDi>050610063500CatheterMY</basicUdiDi>
    <tradeName>cymactive™ 2.0R Bladder Manager System (BMS) Catheter</tradeName>
    <deviceName>cymactive™ 2.0R Bladder Manager System (BMS) Catheter</deviceName>
    <manufacturerName>Ingenion Medical Ltd.</manufacturerName>
    <manufacturerSrn>UK-MF-000041065</manufacturerSrn>
    <authorisedRepresentativeName>CS Life Sciences Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000004113</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010103</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, MALECOT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CYM-2R-12</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:48:19.028Z</lastUpdated>
  </row>
</eudamedExport>