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SoliPACS

by EBM Technologies Inc. EUDAMED

Active European Union

Ref IIaModel SoliPACS Client Viewer；SoliPACS Server； SoliPACS Web Viewer； SoliPACS Gateway ；MobiPACS App ；Rad@

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-TW-MF-000020401W2 Basic UDI-DIDate21 Feb 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
SoliPACS
Model / Reference
SoliPACS Client Viewer；SoliPACS Server； SoliPACS Web Viewer； SoliPACS Gateway ；MobiPACS App ；Rad@, IIa
Primary DI / UDI-DI
D-TW-MF-000020401W2
Basic UDI-DI
B-TW-MF-000020401W2
EMDN Code
Z110603 Picture archiving and communication systems
Device Class
Class IIa
Special Device Type
-1192
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
TW-MF-000020401
Authorised representative
International Associates Auditing & Certification Limited IE-AR-000002248

Other devices from Ebm Technologies, Inc.

  • Ude

    Class II

  • Vsotg

    Class IIb

Properties

Other properties (11)

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