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XR PACS imagepro 8

by D.A.T.A. Corporation EUDAMED

Active European Union

Ref XR PACS imagepro 8

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number912012462IMAGEPRO80JW Basic UDI-DIDate7 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000208388 Issued

    Quality management system EU MDR

    Notified body
    Notified body 0297
    Issued
    9 Oct 2025
    Expires
    8 Oct 2030

Specification

EUDAMED

Model / Reference
XR PACS imagepro 8
Primary DI / UDI-DI
09120124620012
Basic UDI-DI
912012462IMAGEPRO80JW
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
AT-MF-000017422

From the manufacturer

Manufacturer's product page: XR PACS imagepro

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No