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FDR Smart FGX Series

by FUJIFILM Corporation Japan EUDAMED

Ref 04547410548488Model FDR Smart FGX-C40S EMDN Z110310

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-04547410548488 Basic UDI-DIDate30 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
FDR Smart FGX-C40S, 04547410548488
Primary DI / UDI-DI
04547410548488
Basic UDI-DI
B-04547410548488
EMDN Code
Z110310 Multifunctional systems for traditional radiology
Device Class
Class IIb
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000010401
Authorised representative
FUJIFILM Healthcare Europe GmbH DE-AR-000040920

Other devices from Fujifilm Corporation

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Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 04547410548488|B-04547410548488 61 fields · synced 25 Oct 2026