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Fujifilm Bs-2

by Fujifilm Corporation

Ref 04547410331370

Fujifilm Bs-2 is a device classified as Class IIa in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 8 Oct 2026 (Basic UDI-DI 454741020100000000001385K), cleared under FDA 510(k) K040048 on 7 Jun 2004 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 04547410331370), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K040048

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000001385K Basic UDI-DI 04547410331370UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410331370 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK040048 Date7 Jun 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000001385K registered 8 Oct 2026 Active
  • FDA 510(k) K040048 decided 7 Jun 2004 Active
  • FDA GUDID UDI-DI 04547410331370 listed 16 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K040048
  2. Listed FDA GUDID 04547410331370
  3. Registered EUDAMED 454741020100000000001385K

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  • Withdrawn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 BS-2 EUDAMED
Fujifilm GUDID
Generic name
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device name
Balloon 2
Model / reference
04547410331370 EUDAMED
BS-2 GUDID
Primary DI / UDI-DI
04547410331370
Basic UDI-DI
454741020100000000001385K
Unit of use DI
84547410331376
510(k) Number
FDA product code
KNT, FDA
EMDN code
Z12020699 Lower gastrointestinal tract endoscopy instruments - other
GMDN term
Gastrointestinal/biliary dilation balloon catheter, non-medicated
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5980, 876.1500
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
04547410331370
GUDID
BS-2
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 (K040048)

Similar devices in this category

Other devices filed under LOWER 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
  • Manufacturing date
Other properties (18, all answered No)