<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-GXD5PACSRT</udiDi>
    <basicUdiDi>B-GXD5PACSRT</basicUdiDi>
    <tradeName>D-GXD5PACSRT</tradeName>
    <deviceName>GXD5 PACS</deviceName>
    <manufacturerName>ENOVACOM</manufacturerName>
    <manufacturerSrn>FR-MF-000000686</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXD5 PACS</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:50.220Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-GXD5DIAGSGH</udiDi>
    <basicUdiDi>B-GXD5DIAGSGH</basicUdiDi>
    <tradeName>D-GXD5DIAGSGH</tradeName>
    <deviceName>GXD5 DIAGNOSTICS</deviceName>
    <manufacturerName>ENOVACOM</manufacturerName>
    <manufacturerSrn>FR-MF-000000686</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GXD5 Diagnostics 1.9</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:43:49.425Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979WEB673V6</udiDi>
    <basicUdiDi>B-DEMF000004979WEB673V6</basicUdiDi>
    <tradeName>iQ-WEB 6.7.3</tradeName>
    <deviceName>iQ-WEB 6.7.3</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQWEB673</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:10.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979ROUTER40ZH</udiDi>
    <basicUdiDi>B-DEMF000004979ROUTER40ZH</basicUdiDi>
    <tradeName>iQ-ROUTER/PRO/ PREMIUM 4.0</tradeName>
    <deviceName>iQ-ROUTER/PRO/ PREMIUM 4.0</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQROUTER40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:06.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979ROBOT40VJ</udiDi>
    <basicUdiDi>B-DEMF000004979ROBOT40VJ</basicUdiDi>
    <tradeName>iQ-ROBOT/PRO/ PREMIUM 4.0</tradeName>
    <deviceName>iQ-ROBOT/PRO/ PREMIUM 4.0</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IQROBOT40</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:05.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979VIEW313D</udiDi>
    <basicUdiDi>B-DEMF000004979VIEW313D</basicUdiDi>
    <tradeName>iQ-VIEW/PRO 3.1</tradeName>
    <deviceName>iQ-VIEW/PRO 3.1</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQVIEW31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:03.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979VIEW300SM</udiDi>
    <basicUdiDi>B-DEMF000004979VIEW300SM</basicUdiDi>
    <tradeName>iQ-VIEW/PRO 3.0.0</tradeName>
    <deviceName>iQ-VIEW/PRO 3.0.0</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IQVIEW300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:25:03.237Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979LITE31XP</udiDi>
    <basicUdiDi>B-DEMF000004979LITE31XP</basicUdiDi>
    <tradeName>iQ-LITE 3.1</tradeName>
    <deviceName>iQ-LITE 3.1</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQLITE31</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:45.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979LITE300NJ</udiDi>
    <basicUdiDi>B-DEMF000004979LITE300NJ</basicUdiDi>
    <tradeName>iQ-LITE 3.0.0</tradeName>
    <deviceName>iQ-LITE 3.0.0</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>IQLITE300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:45.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF000004979DIREAD60CR</udiDi>
    <basicUdiDi>B-DEMF000004979DIREAD60CR</basicUdiDi>
    <tradeName>DICOMReader/ PRO 6.0</tradeName>
    <deviceName>DICOMReader/ PRO 6.0</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DICOMREADER60</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:44.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF0000049794VIEW22HL</udiDi>
    <basicUdiDi>B-DEMF0000049794VIEW22HL</basicUdiDi>
    <tradeName>iQ-4VIEW 2.2</tradeName>
    <deviceName>iQ-4VIEW 2.2</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQ4VIEW22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:43.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DEMF0000049793D320SC</udiDi>
    <basicUdiDi>B-DEMF0000049793D320SC</basicUdiDi>
    <tradeName>iQ-3D 3.2.0</tradeName>
    <deviceName>iQ-3D 3.2.0</deviceName>
    <manufacturerName>IMAGE Information Systems Europe GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000004979</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IQ3D320</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:39.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-DE-MF-000018915GS</udiDi>
    <basicUdiDi>B-DE-MF-000018915GS</basicUdiDi>
    <tradeName>Telemis</tradeName>
    <deviceName>Hyper.PACS</deviceName>
    <manufacturerName>Telemis GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000018915</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Hyper.PACS V8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:24:05.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CP7tiltGT</udiDi>
    <basicUdiDi>B-CP7tiltGT</basicUdiDi>
    <tradeName>D-CP7tiltGT</tradeName>
    <deviceName>Cadaviz Premium-7 tilt</deviceName>
    <manufacturerName>Immersivevision Technology Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000054987</manufacturerSrn>
    <authorisedRepresentativeName>Immersivevision Technology Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000054050</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069099</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP7tilt</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T04:19:54.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Bonelogic_Neuro_92</udiDi>
    <basicUdiDi>B-Bonelogic_Neuro_92</basicUdiDi>
    <tradeName>Bonelogic Neuro</tradeName>
    <deviceName>Bonelogic Neuro</deviceName>
    <manufacturerName>Disior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bonelogic Neuro</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:32:12.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Bonelogic_CMFOrbital_WP</udiDi>
    <basicUdiDi>B-Bonelogic_CMFOrbital_WP</basicUdiDi>
    <tradeName>Bonelogic CMF Orbital</tradeName>
    <deviceName>Bonelogic CMF Orbital</deviceName>
    <manufacturerName>Disior Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000002448</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bonelogic CMF Orbital</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:32:11.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B319STONECHECKER11ED</udiDi>
    <basicUdiDi>B-B319STONECHECKER11ED</basicUdiDi>
    <tradeName>StoneChecker</tradeName>
    <deviceName>StoneChecker</deviceName>
    <manufacturerName>Imaging Biometrics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033700</manufacturerSrn>
    <authorisedRepresentativeName>Casus Consulting Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000023507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>StoneChecker</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:50:44.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B319LSN10JD</udiDi>
    <basicUdiDi>B-B319LSN10JD</basicUdiDi>
    <tradeName>LSN</tradeName>
    <deviceName>LSN</deviceName>
    <manufacturerName>Imaging Biometrics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033700</manufacturerSrn>
    <authorisedRepresentativeName>Casus Consulting Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000023507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:50:43.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-B319IBCLINIC20GD</udiDi>
    <basicUdiDi>B-B319IBCLINIC20GD</basicUdiDi>
    <tradeName>IB Clinic</tradeName>
    <deviceName>IB Clinic</deviceName>
    <manufacturerName>Imaging Biometrics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000033700</manufacturerSrn>
    <authorisedRepresentativeName>Casus Consulting Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000023507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11069092</emdnCode>
    <emdnDescription>VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IB Clinic</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T18:50:43.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>09120100700240</udiDi>
    <basicUdiDi>912010070aimHG</basicUdiDi>
    <tradeName>synedra AIM 24 Herakles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>synedra information technologies GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000000903</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 Herakles</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T12:57:36.756Z</lastUpdated>
  </row>
</eudamedExport>