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Fujifilm Jt-500

by Fujifilm Corporation

Ref 04547410195743

Fujifilm Jt-500 is a device classified as Class IIa in the EU and Class II in the US made by Fujifilm Corporation, registered in EUDAMED on 13 Oct 2026 (Basic UDI-DI 454741020100000000001425A), cleared under FDA 510(k) K112391 on 26 Jul 2012 and listed in FDA GUDID since 18 Oct 2016 (UDI-DI 04547410195743), 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) K112391

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 Number454741020100000000001425A Basic UDI-DI 04547410195743UDI-DIDate13 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410195743 UDI-DI Date18 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK112391 Date26 Jul 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000001425A registered 13 Oct 2026 Active
  • FDA 510(k) K112391 decided 26 Jul 2012 Active
  • FDA GUDID UDI-DI 04547410195743 listed 18 Oct 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K112391
  2. Listed FDA GUDID 04547410195743
  3. Registered EUDAMED 454741020100000000001425A

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  • Withdrawn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
J Tube JT-500 EUDAMED
Fujifilm GUDID
Generic name
Flexible video colonoscope, reusable
Device name
Tube 5
Model / reference
04547410195743 EUDAMED
JT-500 GUDID
Primary DI / UDI-DI
04547410195743
Basic UDI-DI
454741020100000000001425A
Direct marketing DI
04547410195743
510(k) Number
FDA product code
FDF
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Flexible video colonoscope, reusable
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
04547410195743
GUDID
JT-500
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: Flexible video colonoscope, reusable

Cleared under the same submission (K112391)

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
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)