<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06973661011019</udiDi>
    <basicUdiDi>697366101TBFMMG</basicUdiDi>
    <tradeName>TBAIWELL</tradeName>
    <deviceName>Fetal Monitoring Belts/ CTG Belts</deviceName>
    <manufacturerName>Guangzhou Itingbaby Tech CO., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040579</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB.FM.BP130</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:55:17.762Z</lastUpdated>
  </row>
</eudamedExport>