<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-teamCRAFT54U</udiDi>
    <basicUdiDi>B-teamCRAFT54U</basicUdiDi>
    <tradeName>teamCRAFT5</tradeName>
    <deviceName>teamCRAFT5</deviceName>
    <manufacturerName>Digithurst Bildverarbeitungssysteme GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000006131</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>5.18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:31:25.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TW-MF-000020401W2</udiDi>
    <basicUdiDi>B-TW-MF-000020401W2</basicUdiDi>
    <tradeName>D-TW-MF-000020401W2</tradeName>
    <deviceName>SoliPACS</deviceName>
    <manufacturerName>EBM Technologies Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000020401</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IIa</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:24:27.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TW-MF-0000204011W3SX</udiDi>
    <basicUdiDi>B-TW-MF-0000204011W3SX</basicUdiDi>
    <tradeName>D-TW-MF-0000204011W3SX</tradeName>
    <deviceName>VSOTG</deviceName>
    <manufacturerName>EBM Technologies Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000020401</manufacturerSrn>
    <authorisedRepresentativeName>International Associates Auditing &amp; Certification Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002248</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IIb</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:24:26.372Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869952574</udiDi>
    <basicUdiDi>0405686900137UX</basicUdiDi>
    <tradeName>MI View&amp;GO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Medical Solutions USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016485</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:11.903Z</lastUpdated>
  </row>
  <row>
    <udiDi>04068151027013</udiDi>
    <basicUdiDi>0405686900137UX</basicUdiDi>
    <tradeName>MI View&amp;GO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Medical Solutions USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016485</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VA3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:11.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>04056869257082</udiDi>
    <basicUdiDi>0405686900137UX</basicUdiDi>
    <tradeName>Scenium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Medical Solutions USA, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016485</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011241</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11431542</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:46:11.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ROMF000004762PACSRIS97</udiDi>
    <basicUdiDi>B-ROMF000004762PACSRIS97</basicUdiDi>
    <tradeName>Sistem integrat PixelData PACS-RIS</tradeName>
    <deviceName>PixelData PACS-RIS Integrated System</deviceName>
    <manufacturerName>PixelData SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000004762</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>101010202210222210</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:27:45.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MDD_ZS2PlusKR</udiDi>
    <basicUdiDi>B-MDD_ZS2PlusKR</basicUdiDi>
    <tradeName>D-MDD_ZS2PlusKR</tradeName>
    <deviceName>Ziostation2 Plus</deviceName>
    <manufacturerName>Ziosoft, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000025176</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110603</emdnCode>
    <emdnDescription>PICTURE ARCHIVING AND COMMUNICATION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T02:03:25.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-MARIEPACSPT</udiDi>
    <basicUdiDi>B-MARIEPACSPT</basicUdiDi>
    <tradeName>D-MARIEPACSPT</tradeName>
    <deviceName>MARIE PACS</deviceName>
    <manufacturerName>OR-CZ spol. s r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000028433</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>MPACS–AAAA–MMRR</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-14T01:53:14.090Z</lastUpdated>
  </row>
  <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-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>
</eudamedExport>