<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+EOLENEUROINSIGHTV1P00</udiDi>
    <basicUdiDi>++EOLENEUROINSIGHTPM</basicUdiDi>
    <tradeName>Neuro Insight V1.0</tradeName>
    <deviceName>Neuro Insight V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NI-MR; AP-NI-NP-MR; AP-NI-NS-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:43.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEMRDPMV1P00</udiDi>
    <basicUdiDi>++EOLEMRDPM96</basicUdiDi>
    <tradeName>MR Diffusion Perfusion Mismatch V1.0</tradeName>
    <deviceName>MR Diffusion Perfusion Mismatch V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-DP-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:40.805Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEMRDFMV1P00</udiDi>
    <basicUdiDi>++EOLEMRDFM88</basicUdiDi>
    <tradeName>MR DWI/FLAIR Measurement V1.0</tradeName>
    <deviceName>MR DWI/FLAIR Measurement V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-DF-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:40.735Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEFUNCTIONALMRV1P00</udiDi>
    <basicUdiDi>++EOLEFUNCTIONALMRDS</basicUdiDi>
    <tradeName>Functional MR V1.0</tradeName>
    <deviceName>Functional MR V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MOD030</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:39.622Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLECTPERFUSIONV1P00</udiDi>
    <basicUdiDi>++EOLECTPERFUSIONDG</basicUdiDi>
    <tradeName>CT Perfusion V1.0</tradeName>
    <deviceName>CT Perfusion V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-CTP</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:34.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEBREASTCAPEV1P00</udiDi>
    <basicUdiDi>++EOLEBREASTSCAPEYM</basicUdiDi>
    <tradeName>breastscape V1.0</tradeName>
    <deviceName>breastscape V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCPT001;SCPT002</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:30.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>+EOLEAIDMV1P00</udiDi>
    <basicUdiDi>++EOLEAIDM72</basicUdiDi>
    <tradeName>AI DWI Mismatch V1.0</tradeName>
    <deviceName>AI DWI Mismatch V1.0</deviceName>
    <manufacturerName>Olea Medical S.A.S.</manufacturerName>
    <manufacturerSrn>FR-MF-000002403</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050182</emdnCode>
    <emdnDescription>MMAGNETIC RESONANCE (MR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP-NV-AIDM-MR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:30.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B5450340000010</udiDi>
    <basicUdiDi>++B545034000ZK</basicUdiDi>
    <tradeName>+B5450340000010</tradeName>
    <deviceName>03-4000-00</deviceName>
    <manufacturerName>ASG Superconductors S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029567</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-4000-00 V1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:49:35.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>+B54503200000120</udiDi>
    <basicUdiDi>++B545032000Z5</basicUdiDi>
    <tradeName>MROpen Evo</tradeName>
    <deviceName>Mr Open Evo</deviceName>
    <manufacturerName>ASG Superconductors S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000029567</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050102</emdnCode>
    <emdnDescription>OPEN MAGNET MRI SCANNERS WITH MAGNETIC FIELD INTENSITY LESS THAN OR EQUAL TO 0.5T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03-2000-00 V12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:49:31.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-NR-LEGACY-001UN</udiDi>
    <basicUdiDi>B-NR-LEGACY-001UN</basicUdiDi>
    <tradeName>Neuroreader</tradeName>
    <deviceName>Neuroreader</deviceName>
    <manufacturerName>Brainreader A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000030456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11050192</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR-LEGACY-001</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:24:11.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FR-MF-0000079194Y</udiDi>
    <basicUdiDi>B-FR-MF-0000079194Y</basicUdiDi>
    <tradeName>MRI Pad</tradeName>
    <deviceName>MRI Pad</deviceName>
    <manufacturerName>Multiwave Imaging</manufacturerName>
    <manufacturerSrn>FR-MF-000007919</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7 TNS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:39:25.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850011472177</udiDi>
    <basicUdiDi>B-10850011472177</basicUdiDi>
    <tradeName>Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)</tradeName>
    <deviceName>Endorectal MRI Coil for 3.0T MR Imaging of the Prostate (eCoil®)</deviceName>
    <manufacturerName>DxTx Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026795</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018002</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPX 30</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:23.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>10850011472146</udiDi>
    <basicUdiDi>B-10850011472146</basicUdiDi>
    <tradeName>Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)</tradeName>
    <deviceName>Endorectal MRI Coil for 1.5T MR Imaging of the Prostate (eCoil®)</deviceName>
    <manufacturerName>DxTx Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000026795</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018002</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) RADIOFREQUENCY VOLUMETRIC COILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BPX 15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:36:22.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151995114</udiDi>
    <basicUdiDi>0405686902279W2</basicUdiDi>
    <tradeName>MAGNETOM Altea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11344915</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:33.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869230726</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Altea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11410371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:32.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151995121</udiDi>
    <basicUdiDi>0405686902279W2</basicUdiDi>
    <tradeName>MAGNETOM Altea</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthineers AG</manufacturerName>
    <manufacturerSrn>DE-MF-000038456</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11410371</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:58:32.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869299266</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Avanto Fit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11516216</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:57:57.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869975221</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Cima.X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11647158</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:56:32.905Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869996509</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Cima.X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11689616</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:56:07.389Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869975245</udiDi>
    <basicUdiDi>0405686900125UQ</basicUdiDi>
    <tradeName>MAGNETOM Cima.X</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006122</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11050104</emdnCode>
    <emdnDescription>CLOSED MAGNET MRI SCANNERS WITH MAGNETIC FIELD LESS THAN OR EQUAL TO 2T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11689304</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T19:56:06.968Z</lastUpdated>
  </row>
</eudamedExport>