<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977405630009</udiDi>
    <basicUdiDi>697740563000LH</basicUdiDi>
    <tradeName>06977405630009</tradeName>
    <deviceName>BigEasy® Non-Rebreathing Valve and Mask Kit</deviceName>
    <manufacturerName>Flying Tooling Engineering Limited</manufacturerName>
    <manufacturerSrn>CN-MF-000041571</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R030199</emdnCode>
    <emdnDescription>RESPIRATORY MASKS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33-90003</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:33:08.124Z</lastUpdated>
  </row>
</eudamedExport>