<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>05060737370017</udiDi>
    <basicUdiDi>506073737CHQL</basicUdiDi>
    <tradeName>05060737370017</tradeName>
    <deviceName>CaRi-Heart</deviceName>
    <manufacturerName>Caristo Diagnostics Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023066</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050592</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:52:56.187Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860005876808</udiDi>
    <basicUdiDi>0860005876801UZ</basicUdiDi>
    <tradeName>Us2.v1</tradeName>
    <deviceName>Us2.v1</deviceName>
    <manufacturerName>Eko.ai Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000033904</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050592</emdnCode>
    <emdnDescription>CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOC015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:51:25.430Z</lastUpdated>
  </row>
</eudamedExport>