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Fujifilm B20UR

by Fujifilm Corporation

Ref 04547410331561

Fujifilm B20UR is a device classified as Class IIa in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 6 Oct 2026 (Basic UDI-DI 454741020100000000001665Q), cleared under FDA 510(k) K120446 on 13 Aug 2012 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410331561), active as of 7 Nov 2026. One FDA recall is linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K120446

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000001665Q Basic UDI-DI 04547410331561UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410331561 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK120446 Date13 Aug 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000001665Q registered 6 Oct 2026 Active
  • FDA 510(k) K120446 decided 13 Aug 2012 Active
  • FDA GUDID UDI-DI 04547410331561 listed 16 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0112-2014 FDA Class II initiated 31 Jul 2013

    A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.

Timeline

4 dated events

  1. Cleared FDA 510(k) K120446
  2. Recall initiated FDA recalls Z-0112-2014
  3. Listed FDA GUDID 04547410331561
  4. Registered EUDAMED 454741020100000000001665Q

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Balloon for Ultrasonography B20UR EUDAMED
Fujifilm GUDID
Generic name
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device name
Balloon for Ultrasonography 3
Model / reference
04547410331561 EUDAMED
B20UR GUDID
Primary DI / UDI-DI
04547410331561
Basic UDI-DI
454741020100000000001665Q
Unit of use DI
84547410331567
510(k) Number
FDA product code
FDS, ITX
EMDN code
Z12020599 Upper gastrointestinal tract endoscopy instruments - other
GMDN term
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500, 892.1570
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410331561
GUDID
B20UR
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Gastrointestinal/biliary dilation balloon catheter, non-medicated

Cleared under the same submission (K120446)

Similar devices in this category

Other devices filed under UPPER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Sterilise before use
  • Single use
  • Contains latex
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)