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<eudamedExport entity="devices">
  <row>
    <udiDi>19005531002163</udiDi>
    <basicUdiDi>9005531ECGElectrodesCM</basicUdiDi>
    <tradeName>RATIOMED</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leonhard Lang GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000000426</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020501</emdnCode>
    <emdnDescription>ECG ELECTRODES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>164015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:08.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>M582DR4004G</udiDi>
    <basicUdiDi>B-M582DR4004G</basicUdiDi>
    <tradeName>DR400</tradeName>
    <deviceName>NorthEast DR400 Holter Recorder</deviceName>
    <manufacturerName>NorthEast Monitoring, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019819</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DR400</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:30.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>M582DR20046</udiDi>
    <basicUdiDi>B-M582DR20046</basicUdiDi>
    <tradeName>DR200</tradeName>
    <deviceName>NorthEast DR200 Holter Recorder</deviceName>
    <manufacturerName>NorthEast Monitoring, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019819</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DR200</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:28.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>M582AnalysisSoftwareH4</udiDi>
    <basicUdiDi>B-M582AnalysisSoftwareH4</basicUdiDi>
    <tradeName>Analysis Software</tradeName>
    <deviceName>Analysis Software</deviceName>
    <manufacturerName>NorthEast Monitoring, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019819</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>Holter LX Analysis</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:58:26.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-CA01-2017-1778GV</udiDi>
    <basicUdiDi>B-FI-CA01-2017-1778GV</basicUdiDi>
    <tradeName>TeleCardio</tradeName>
    <deviceName>TeleCardio</deviceName>
    <manufacturerName>Oy Diagnostic Devices Development</manufacturerName>
    <manufacturerSrn>FI-MF-000017197</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>02</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:39.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FI-CA01-2017-1777GT</udiDi>
    <basicUdiDi>B-FI-CA01-2017-1777GT</basicUdiDi>
    <tradeName>Cardio Mobile</tradeName>
    <deviceName>CardioMobile</deviceName>
    <manufacturerName>Oy Diagnostic Devices Development</manufacturerName>
    <manufacturerSrn>FI-MF-000017197</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:27:36.513Z</lastUpdated>
  </row>
  <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>34255650100731</udiDi>
    <basicUdiDi>B-34255650100731</basicUdiDi>
    <tradeName>Tubing set H500</tradeName>
    <deviceName>HAT500/LiveCool 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>103-003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:22:11.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>24255650100734</udiDi>
    <basicUdiDi>B-24255650100734</basicUdiDi>
    <tradeName>LiveCOOL Tubing set</tradeName>
    <deviceName>liveCOOL Tubing Set (H500)</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>143-001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:41:12.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>24255650100710</udiDi>
    <basicUdiDi>B-24255650100710</basicUdiDi>
    <tradeName>Tubing set CF</tradeName>
    <deviceName>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>61111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:41:11.656Z</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>
</eudamedExport>