<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  <row>
    <udiDi>18904269470057</udiDi>
    <basicUdiDi>B-18904269470057</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>F3-18-390-0080-49</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:59.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470040</udiDi>
    <basicUdiDi>B-18904269470040</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>F3-18-390-0079-52</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:56.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470033</udiDi>
    <basicUdiDi>B-18904269470033</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>F3-18-390-0078-55</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:54.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>18904269470026</udiDi>
    <basicUdiDi>B-18904269470026</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>F3-18-390-0077-58</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:29:54.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100751</udiDi>
    <basicUdiDi>B-14255650100751</basicUdiDi>
    <tradeName>Tubing set SmA</tradeName>
    <deviceName>Irrigation tubing set SmA</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0280</emdnCode>
    <emdnDescription>ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:58.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100744</udiDi>
    <basicUdiDi>B-14255650100744</basicUdiDi>
    <tradeName>Tubing set MQ</tradeName>
    <deviceName>Irrigation tubing set MQ</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0280</emdnCode>
    <emdnDescription>ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:57.519Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100737</udiDi>
    <basicUdiDi>B-14255650100737</basicUdiDi>
    <tradeName>HAT500 Tubing set</tradeName>
    <deviceName>HAT500 Tubing set</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0280</emdnCode>
    <emdnDescription>ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:56.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100720</udiDi>
    <basicUdiDi>B-14255650100720</basicUdiDi>
    <tradeName>Tubing Set CF incl.caps</tradeName>
    <deviceName>Tubing Set CF incl. caps</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0280</emdnCode>
    <emdnDescription>ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:55.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100713</udiDi>
    <basicUdiDi>B-14255650100713</basicUdiDi>
    <tradeName>Tubing set CF</tradeName>
    <deviceName>Irrigation tubing set CF</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0280</emdnCode>
    <emdnDescription>ARRYTHMOLOGY DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>103-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:51.915Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100508</udiDi>
    <basicUdiDi>B-14255650100508</basicUdiDi>
    <tradeName>EasyMap MAP XL (90mm)</tradeName>
    <deviceName>EasyMap MAP XL</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:51.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>14255650100492</udiDi>
    <basicUdiDi>B-14255650100492</basicUdiDi>
    <tradeName>EasyMap MAP L (80mm)</tradeName>
    <deviceName>EasyMap MAP L</deviceName>
    <manufacturerName>MedFact Engineering GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010098</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>106-212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T04:57:50.322Z</lastUpdated>
  </row>
</eudamedExport>