<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00051940000308</udiDi>
    <basicUdiDi>78989943936CS550UB</basicUdiDi>
    <tradeName>CardioSmart CS550 EN</tradeName>
    <deviceName>CARDIOSMART CS550 HOLTER ANALYSIS SOFTWARE</deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050401</emdnCode>
    <emdnDescription>CARDIOVASCULAR HOLTER ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05194000030</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:35.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00051901000118</udiDi>
    <basicUdiDi>78989943936CardioLight+3T</basicUdiDi>
    <tradeName>CardioLight+</tradeName>
    <deviceName>Cardios Digital Holter Recorder</deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05190100011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:08:34.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>00051901000132</udiDi>
    <basicUdiDi>78989943936CardioLight+3T</basicUdiDi>
    <tradeName>CardioLight+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05190100013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:11:50.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00051901000149</udiDi>
    <basicUdiDi>78989943936CardioLight+3T</basicUdiDi>
    <tradeName>CardioLight+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05190100014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:11:50.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>00051940000346</udiDi>
    <basicUdiDi>78989943936CS550UB</basicUdiDi>
    <tradeName>CardioSmart CS550 ES</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050401</emdnCode>
    <emdnDescription>CARDIOVASCULAR HOLTER ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05194000034</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:11:50.178Z</lastUpdated>
  </row>
  <row>
    <udiDi>00051940000384</udiDi>
    <basicUdiDi>78989943936CS550UB</basicUdiDi>
    <tradeName>CardioSmart CS550 FR</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050401</emdnCode>
    <emdnDescription>CARDIOVASCULAR HOLTER ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05194000038</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:11:50.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00051950000138</udiDi>
    <basicUdiDi>78989943936CardioLight+3T</basicUdiDi>
    <tradeName>Patient Cable CL 4 Leads</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cardio Sistemas Comercial e Industrial Ltda</manufacturerName>
    <manufacturerSrn>BR-MF-000024824</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12050403</emdnCode>
    <emdnDescription>ECG HOLTER RECORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>05195000013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-28T19:11:50.129Z</lastUpdated>
  </row>
</eudamedExport>