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FUJI Medical X-ray Film

by FUJIFILM Corporation 20 variants

Ref 4741019339

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

27 Jun 2029

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4547410101000000000000132 Basic UDI-DI 04547410193398UDI-DIDate25 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410193398 UDI-DI Date7 Oct 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 4203162CE01 Active Amended

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    15 Jul 2024
    Expires
    27 Jun 2029
    Reason
    Mnf ar change

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Medical x-ray film, screen
Model / Ref / Catalog
4741019339, SUPER RX-N 35X43 500 E
Primary DI / UDI-DI
04547410193398
Basic UDI-DI
4547410101000000000000132
Unit of Use DI
84547410193394
FDA Product Code
IWZ
EMDN Code
Z130101 General purpose x-ray films
GMDN Term
Medical x-ray film, screen
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
892.1840
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
4741019339
GUDID
SUPER RX-N 35X43 500 E
Device ClassEUDAMED
Class IIa
GUDID
Class I

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

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No