<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06976654651001</udiDi>
    <basicUdiDi>697665465BI01NH</basicUdiDi>
    <tradeName>UGAIYA/FULCARE</tradeName>
    <deviceName>Rapid Readout Biological Indicator / Biological Indicator</deviceName>
    <manufacturerName>CHENGDU FULCARE TRADING CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000037249</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UGBI0101</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:53:01.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>06976654650004</udiDi>
    <basicUdiDi>697665465CI01NQ</basicUdiDi>
    <tradeName>UGAIYA/FULCARE</tradeName>
    <deviceName>Chemical Indicator</deviceName>
    <manufacturerName>CHENGDU FULCARE TRADING CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000037249</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UGCI0104</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T18:52:56.711Z</lastUpdated>
  </row>
</eudamedExport>