<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-789850904IONXYXG</udiDi>
    <basicUdiDi>B-789850904IONXYXG</basicUdiDi>
    <tradeName>I.ON</tradeName>
    <deviceName>I.ON</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>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I.ON</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:02.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-789850904IONPRO3ETT</udiDi>
    <basicUdiDi>B-789850904IONPRO3ETT</basicUdiDi>
    <tradeName>I.ON PRO</tradeName>
    <deviceName>i.on pro</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>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I.ON PRO</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:58.136Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-789850904CARDIOMAXYTM6</udiDi>
    <basicUdiDi>B-789850904CARDIOMAXYTM6</basicUdiDi>
    <tradeName>CARDIOMAX</tradeName>
    <deviceName>Cardiomax</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>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cardiomax</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:57.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-789850904DUALMAX7Z72</udiDi>
    <basicUdiDi>B-789850904DUALMAX7Z72</basicUdiDi>
    <tradeName>Dualmax</tradeName>
    <deviceName>Dualmax</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>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Dualmax</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:26:55.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470774</udiDi>
    <basicUdiDi>B-18904269470774</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0159-06</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:25.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470767</udiDi>
    <basicUdiDi>B-18904269470767</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0146-45</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:21.304Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470750</udiDi>
    <basicUdiDi>B-18904269470750</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0145-48</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:20.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470743</udiDi>
    <basicUdiDi>B-18904269470743</basicUdiDi>
    <tradeName>CardiAid Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0148-39</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:19.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470736</udiDi>
    <basicUdiDi>B-18904269470736</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0129-96</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:18.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470729</udiDi>
    <basicUdiDi>B-18904269470729</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0128-02</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:14.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470712</udiDi>
    <basicUdiDi>B-18904269470712</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0087-28</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:14.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470705</udiDi>
    <basicUdiDi>B-18904269470705</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0086-31</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:13.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470699</udiDi>
    <basicUdiDi>B-18904269470699</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0085-34</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:12.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470682</udiDi>
    <basicUdiDi>B-18904269470682</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0084-37</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:09.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470675</udiDi>
    <basicUdiDi>B-18904269470675</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0083-40</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:08.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470668</udiDi>
    <basicUdiDi>B-18904269470668</basicUdiDi>
    <tradeName>CardiAid Pro+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0082-43</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:07.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470651</udiDi>
    <basicUdiDi>B-18904269470651</basicUdiDi>
    <tradeName>CardiAid Pro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0017-44</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:06.094Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470088</udiDi>
    <basicUdiDi>B-18904269470088</basicUdiDi>
    <tradeName>SkanRevive+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0127-05</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:02.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470071</udiDi>
    <basicUdiDi>B-18904269470071</basicUdiDi>
    <tradeName>SkanRevive+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0126-08</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:01.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470064</udiDi>
    <basicUdiDi>B-18904269470064</basicUdiDi>
    <tradeName>SkanRevive+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SKANRAY TECHNOLOGIES LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000034819</manufacturerSrn>
    <authorisedRepresentativeName>SKANRAY EUROPE SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000013034</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020499</emdnCode>
    <emdnDescription>EXTERNAL CARDIOVERSION AND DEFIBRILLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F3-18-390-0081-46</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:30:00.491Z</lastUpdated>
  </row>
</eudamedExport>