<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>03857500135612</udiDi>
    <basicUdiDi>38575001356IPK1V5</basicUdiDi>
    <tradeName>iRIS PACS</tradeName>
    <deviceName>iRIS PACS</deviceName>
    <manufacturerName>INFOMEDICA za proizvodnju i promet medicinskim proizvodima, društvo s ograničenom odgovornošću</manufacturerName>
    <manufacturerSrn>HR-MF-000035358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IPK11000</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:32:48.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>37700180710082</udiDi>
    <basicUdiDi>3770018071008VP</basicUdiDi>
    <tradeName>Rayvolve</tradeName>
    <deviceName>Rayvolve</deviceName>
    <manufacturerName>AZmed</manufacturerName>
    <manufacturerSrn>FR-MF-000014277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11060282</emdnCode>
    <emdnDescription>DIGITAL COMPUTED RADIOGRAPHY (CR) SYSTEMS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rayvolve- On premise (Version 2)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:01:01.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770019599167</udiDi>
    <basicUdiDi>3770019599AIv16J</basicUdiDi>
    <tradeName>inHEART Models AI</tradeName>
    <deviceName>inHEART Models AI</deviceName>
    <manufacturerName>inHEART</manufacturerName>
    <manufacturerSrn>FR-MF-000006723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:58:16.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770019599129</udiDi>
    <basicUdiDi>3770019599Portalv42J</basicUdiDi>
    <tradeName>inHEART Portal</tradeName>
    <deviceName>inHEART Portal</deviceName>
    <manufacturerName>inHEART</manufacturerName>
    <manufacturerSrn>FR-MF-000006723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v4</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:58:15.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770019599105</udiDi>
    <basicUdiDi>3770019599Explorerv2P5</basicUdiDi>
    <tradeName>inHEART Models Explorer</tradeName>
    <deviceName>inHEART Models Explorer</deviceName>
    <manufacturerName>inHEART</manufacturerName>
    <manufacturerSrn>FR-MF-000006723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:58:14.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>03770019599044</udiDi>
    <basicUdiDi>3770019599Shaperv1RU</basicUdiDi>
    <tradeName>inHEART Models Shaper</tradeName>
    <deviceName>inHEART Models Shaper</deviceName>
    <manufacturerName>inHEART</manufacturerName>
    <manufacturerSrn>FR-MF-000006723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:58:12.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>37603642100158</udiDi>
    <basicUdiDi>376036421PACSAX</basicUdiDi>
    <tradeName>37603642100158</tradeName>
    <deviceName>GXD5 PACS version 4</deviceName>
    <manufacturerName>ENOVACOM</manufacturerName>
    <manufacturerSrn>FR-MF-000000686</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PACS (LIC-PACS*)</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:40:36.382Z</lastUpdated>
  </row>
  <row>
    <udiDi>37603140600730</udiDi>
    <basicUdiDi>376031406EZDSERVERGV</basicUdiDi>
    <tradeName>Ultima Burner</tradeName>
    <deviceName>Ez Dicom Server</deviceName>
    <manufacturerName>MPTronic</manufacturerName>
    <manufacturerSrn>FR-MF-000014183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ez Dicom Server</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:30:34.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>37603140600426</udiDi>
    <basicUdiDi>376031406EZDPRINTTOPACS27</basicUdiDi>
    <tradeName>Ultima Print To PACS</tradeName>
    <deviceName>Ez Dicom Print To PACS</deviceName>
    <manufacturerName>MPTronic</manufacturerName>
    <manufacturerSrn>FR-MF-000014183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ez Dicom Print To PACS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:30:33.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>37603140600358</udiDi>
    <basicUdiDi>376031406EZDPRINTERA2</basicUdiDi>
    <tradeName>Ultima Print Server</tradeName>
    <deviceName>Ez Dicom Printer</deviceName>
    <manufacturerName>MPTronic</manufacturerName>
    <manufacturerSrn>FR-MF-000014183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ez Dicom Printer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:30:32.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>37603140600280</udiDi>
    <basicUdiDi>376031406EZDMIMPORTER5B</basicUdiDi>
    <tradeName>Ultima Media Importer</tradeName>
    <deviceName>Ez Dicom Media Importer</deviceName>
    <manufacturerName>MPTronic</manufacturerName>
    <manufacturerSrn>FR-MF-000014183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ez Dicom Media Importer</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:30:29.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>37603140600112</udiDi>
    <basicUdiDi>376031406EZDCONVERTERZ5</basicUdiDi>
    <tradeName>Ultima DICOM Converter</tradeName>
    <deviceName>Ez Dicom Converter</deviceName>
    <manufacturerName>MPTronic</manufacturerName>
    <manufacturerSrn>FR-MF-000014183</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ez Dicom Converter</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:30:28.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760332080022</udiDi>
    <basicUdiDi>376033208PAROSA6</basicUdiDi>
    <tradeName>PAROS</tradeName>
    <deviceName>PAROS</deviceName>
    <manufacturerName>INCEPTO MEDICAL SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000007545</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAROS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:26:19.773Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760332080015</udiDi>
    <basicUdiDi>376033208ARVA9Q</basicUdiDi>
    <tradeName>ARVA</tradeName>
    <deviceName>ARVA</deviceName>
    <manufacturerName>INCEPTO MEDICAL SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000007545</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARVA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:26:18.969Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760332080008</udiDi>
    <basicUdiDi>376033208KEROS9B</basicUdiDi>
    <tradeName>KEROS</tradeName>
    <deviceName>KEROS</deviceName>
    <manufacturerName>INCEPTO MEDICAL SAS</manufacturerName>
    <manufacturerSrn>FR-MF-000007545</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>KEROS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T12:26:17.377Z</lastUpdated>
  </row>
  <row>
    <udiDi>03701313000479</udiDi>
    <basicUdiDi>37013130KBA3DSFTWDB</basicUdiDi>
    <tradeName>KBA3D</tradeName>
    <deviceName>KEOPS Balance Analyzer 3D</deviceName>
    <manufacturerName>S.M.A.I.O</manufacturerName>
    <manufacturerSrn>FR-MF-000002399</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v1.1.x</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:48:28.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700719701102</udiDi>
    <basicUdiDi>37007197DUOncoBoneJJ</basicUdiDi>
    <tradeName>DUOnco Bone v1</tradeName>
    <deviceName>DUOnco Bone</deviceName>
    <manufacturerName>INTRASENSE</manufacturerName>
    <manufacturerSrn>FR-MF-000001551</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUOnco Bone v1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:36.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700719700716</udiDi>
    <basicUdiDi>37007197DUOncoPancreas3E</basicUdiDi>
    <tradeName>DUOnco Pancreas 1.0</tradeName>
    <deviceName>DUOnco Pancreas</deviceName>
    <manufacturerName>INTRASENSE</manufacturerName>
    <manufacturerSrn>FR-MF-000001551</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069082</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUOnco Pancreas 1.0</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:35.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700719700709</udiDi>
    <basicUdiDi>37007197LiflowAQ</basicUdiDi>
    <tradeName>Liflow 2.0</tradeName>
    <deviceName>Liflow</deviceName>
    <manufacturerName>INTRASENSE</manufacturerName>
    <manufacturerSrn>FR-MF-000001551</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069005</emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Liflow 2.0</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:34.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700719700693</udiDi>
    <basicUdiDi>37007197DUOncoLiverUG</basicUdiDi>
    <tradeName>DUOnco liver v1.0</tradeName>
    <deviceName>DUOnco liver</deviceName>
    <manufacturerName>INTRASENSE</manufacturerName>
    <manufacturerSrn>FR-MF-000001551</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11069005</emdnCode>
    <emdnDescription>DIAGNOSTIC IMAGING WORKSTATIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DUOnco liver v1.0</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:29:30.500Z</lastUpdated>
  </row>
</eudamedExport>