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Fujifilm St-01B

by Fujifilm Corporation

Ref 04547410079173

Fujifilm St-01B is a Class I device made by Fujifilm Corporation, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 4547410201000000000003456) and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 04547410079173), 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4547410201000000000003456 Basic UDI-DI 04547410079173UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410079173 UDI-DI Date7 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4547410201000000000003456 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 04547410079173 listed 7 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04547410079173
  2. Registered EUDAMED 4547410201000000000003456

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  • Withdrawn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
Setting tool ST-01B EUDAMED
Fujifilm GUDID
Generic name
Endoscope balloon positioner, reusable
Device name
Setting tool 1
Model / reference
04547410079173 EUDAMED
ST-01B GUDID
Primary DI / UDI-DI
04547410079173
Basic UDI-DI
4547410201000000000003456
Direct marketing DI
04547410079173
FDA product code
FFY
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Endoscope balloon positioner, reusable
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
04547410079173
GUDID
ST-01B

Related devices

Category: Endoscope balloon positioner, reusable

Similar devices

Also classified as Endoscope balloon positioner, reusable.

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

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