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Fujifilm B20BU

by Fujifilm Corporation

Ref 04547410333435

Fujifilm B20BU is a bronchial balloon catheter (EU MDR Class IIa; FDA Class II) made by Fujifilm Corporation, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI 454741020100000000001355D), cleared under FDA 510(k) K121035 on 4 Jun 2012 and listed in FDA GUDID since 30 Dec 2016 (UDI-DI 04547410333435), active as of 25 Oct 2026.

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 found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121035

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000001355D Basic UDI-DI 04547410333435UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410333435 UDI-DI Date30 Dec 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121035 Date4 Jun 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000001355D registered 7 Oct 2026 Active
  • FDA 510(k) K121035 decided 4 Jun 2012 Active
  • FDA GUDID UDI-DI 04547410333435 listed 30 Dec 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K121035
  2. Listed FDA GUDID 04547410333435
  3. Registered EUDAMED 454741020100000000001355D

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  • Withdrawn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 B20BU EUDAMED
Fujifilm GUDID
Generic name
Bronchial balloon catheter
Device name
Balloon for Ultrasonography 1
Model / reference
04547410333435 EUDAMED
B20BU GUDID
Primary DI / UDI-DI
04547410333435
Basic UDI-DI
454741020100000000001355D
510(k) Number
FDA product code
EOQ, ITX
EMDN code
R0799 Broncopulmonary endoscopy devices, single-use - other
GMDN term
Bronchial balloon catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
874.4680, 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
04547410333435
GUDID
B20BU
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: Bronchial balloon catheter

Cleared under the same submission (K121035)

Similar devices in this category

Other devices filed under BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER.

Other devices from Fujifilm Corporation

See all devices from Fujifilm Corporation →

Properties

  • Supplied sterile
  • Single use
  • Contains latex
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)