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FCR PROFECT CS Plus

by FUJIFILM Corporation Japan EUDAMED

Ref 04547410422627

EMDN Z11060202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number454741010100000000000143B Basic UDI-DIDate17 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Cr-Ir 363
Model / Reference
04547410422627
Primary DI / UDI-DI
04547410422627
Basic UDI-DI
454741010100000000000143B
EMDN Code
Z11060202 Multiple-input computed radiography (cr) systems
Device Class
Class IIa
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

See all devices from Fujifilm Corporation →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 0e6b3a25-e004-4fb7-aec7-63675079b8ac 61 fields · synced 22 Oct 2026