<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05060470380083</udiDi>
    <basicUdiDi>506047038InfantGuardianX7</basicUdiDi>
    <tradeName>INFANT-Guardian</tradeName>
    <deviceName>K2 INFANT-Guardian®</deviceName>
    <manufacturerName>K2 Medical Systems</manufacturerName>
    <manufacturerSrn>GB-MF-000019924</manufacturerSrn>
    <authorisedRepresentativeName>Picis Clinical Solutions, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019764</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080392</emdnCode>
    <emdnDescription>VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>INFANT-Guardian</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:42.975Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060470380045</udiDi>
    <basicUdiDi>506047038FetalWellbeingNS</basicUdiDi>
    <tradeName>K2 Fetal  Wellbeing™</tradeName>
    <deviceName>K2 Fetal Wellbeing™</deviceName>
    <manufacturerName>K2 Medical Systems</manufacturerName>
    <manufacturerSrn>GB-MF-000019924</manufacturerSrn>
    <authorisedRepresentativeName>Picis Clinical Solutions, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080392</emdnCode>
    <emdnDescription>VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Fetal  Wellbeing</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:18:42.171Z</lastUpdated>
  </row>
</eudamedExport>