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Fujifilm Ca-611

by Fujifilm Corporation

Ref 04547410297386

Fujifilm Ca-611 is an endoscope flushing adaptor (EU MDR Class I; FDA Class I; FDA product code FFY, Adaptor, bulbs, miscellaneous, for endoscope) made by Fujifilm Corporation, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 454741020100000000000104Q) and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 04547410297386), active as of 7 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number454741020100000000000104Q Basic UDI-DI 04547410297386UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04547410297386 UDI-DI Date7 Oct 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 454741020100000000000104Q registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 04547410297386 listed 7 Oct 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04547410297386
  2. Registered EUDAMED 454741020100000000000104Q

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Air/Water Channel Cleaning Adapter CA-611 EUDAMED
Fujifilm GUDID
Generic name
Endoscope flushing adaptor, reusable
Device name
Air/Water Channel Cleaning Adapter 2
Model / reference
04547410297386 EUDAMED
CA-611 GUDID
Primary DI / UDI-DI
04547410297386
Basic UDI-DI
454741020100000000000104Q
Direct marketing DI
04547410297386
FDA product code
FFY
EMDN code
Z12029099 Various instruments for endoscopy and mini–invasive surgery – other
GMDN term
Endoscope flushing adaptor, reusable
Device class
Class I
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
04547410297386
GUDID
CA-611
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 04547410297386: EUDAMED states No, FDA GUDID states Yes.

Related devices

Category: Endoscope flushing adaptor, reusable

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 NoEUDAMEDYesGUDID
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)