<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-789850904CARDIOMAXYTM6</udiDi>
    <basicUdiDi>B-789850904CARDIOMAXYTM6</basicUdiDi>
    <tradeName>CARDIOMAX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTRAMED INDÚSTRIA MÉDICO HOSPITALAR LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000033452</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cardiomax</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:43.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-789850904DUALMAX7Z72</udiDi>
    <basicUdiDi>B-789850904DUALMAX7Z72</basicUdiDi>
    <tradeName>Dualmax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTRAMED INDÚSTRIA MÉDICO HOSPITALAR LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000033452</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Dualmax</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:43.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-789850904IONPRO3ETT</udiDi>
    <basicUdiDi>B-789850904IONPRO3ETT</basicUdiDi>
    <tradeName>I.ON PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTRAMED INDÚSTRIA MÉDICO HOSPITALAR LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000033452</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I.ON PRO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:43.067Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-789850904IONXYXG</udiDi>
    <basicUdiDi>B-789850904IONXYXG</basicUdiDi>
    <tradeName>I.ON</tradeName>
    <deviceName></deviceName>
    <manufacturerName>INSTRAMED INDÚSTRIA MÉDICO HOSPITALAR LTDA.</manufacturerName>
    <manufacturerSrn>BR-MF-000033452</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I.ON</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:43:43.050Z</lastUpdated>
  </row>
</eudamedExport>