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Fujifilm Ts-12140

by Fujifilm Corporation

Ref 04547410331493

Fujifilm Ts-12140 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 454741020100000000001285G), cleared under FDA 510(k) K091773 on 7 Aug 2009 and listed in FDA GUDID since 18 Oct 2016 (UDI-DI 04547410331493), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K091773

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000001285G Basic UDI-DI 04547410331493UDI-DIDate6 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410331493 UDI-DI Date18 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK091773 Date7 Aug 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000001285G registered 6 Oct 2026 Active
  • FDA 510(k) K091773 decided 7 Aug 2009 Active
  • FDA GUDID UDI-DI 04547410331493 listed 18 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K091773
  2. Listed FDA GUDID 04547410331493
  3. Registered EUDAMED 454741020100000000001285G

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  • Withdrawn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
Over-tube TS-12140 EUDAMED
Fujifilm GUDID
Generic name
Endoscopic overtube, single-use
Device name
Over-tube 2
Model / reference
04547410331493 EUDAMED
TS-12140 GUDID
Primary DI / UDI-DI
04547410331493
Basic UDI-DI
454741020100000000001285G
510(k) Number
FDA product code
FED
EMDN code
G030899 Instruments for gastro-intestinal endoscopy and eco-endoscopy, single-use - other
GMDN term
Endoscopic overtube, single-use
Device class
Class IIa EUDAMED
Class II GUDID
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
04547410331493
GUDID
TS-12140
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: Endoscopic overtube, single-use

Cleared under the same submission (K091773)

Similar devices in this category

Other devices filed under INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, 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
Other properties (19, all answered No)