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Fujifilm WB1318DE

by Fujifilm Corporation

Ref 04547410341355

Fujifilm WB1318DE is a Class I device made by Fujifilm Corporation, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 454741020100000000000014P) and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 04547410341355), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000000014P Basic UDI-DI 04547410341355UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410341355 UDI-DI Date7 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000000014P registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 04547410341355 listed 7 Oct 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 04547410341355
  2. Registered EUDAMED 454741020100000000000014P

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  • Withdrawn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

Trade name
Cleaning Brush WB1318DE EUDAMED
Fujifilm GUDID
Generic name
Surgical instrument/endoscope cleaning utensil, single-use
Device name
Cleaning Brush 2
Model / reference
04547410341355 EUDAMED
WB1318DE GUDID
Primary DI / UDI-DI
04547410341355
Basic UDI-DI
454741020100000000000014P
FDA product code
MNL
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Surgical instrument/endoscope cleaning utensil, single-use
Device class
Class I
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410341355
GUDID
WB1318DE

Related devices

Category: Surgical instrument/endoscope cleaning utensil, single-use

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)