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Cofoe KFZX619

by Cofoe Medical Technology Co., Ltd

Part of a family of 8 devices: see the family page

Ref KFZX619Model KFGZ001， KFGZ002， KFGZ003， KFGZ005， KFGZ006， KFGZ007， KFGZ008， KFGZ009，etc.

Cofoe KFZX619 is a Class I device made by Cofoe Medical Technology Co., Ltd, registered in EUDAMED on 24 Jul 2026 (Basic UDI-DI 69507155CAD9) and listed in FDA GUDID since 29 Jul 2024 (UDI-DI 06950715572764), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69507155CAD9 Basic UDI-DI 06950715572764UDI-DIDate24 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06950715572764 UDI-DI Date29 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69507155CAD9 registered 24 Jul 2026 Active
  • FDA GUDID UDI-DI 06950715572764 listed 29 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06950715572764
  2. Registered EUDAMED 69507155CAD9

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  • Withdrawn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
ALBA Mobility Aids EUDAMED
Cofoe GUDID
Generic name
Walker tray
Device name
Mobility Aids
Model / reference
KFZX619, KFGZ001， KFGZ002， KFGZ003， KFGZ005， KFGZ006， KFGZ007， KFGZ008， KFGZ009，etc.
Primary DI / UDI-DI
06950715572764 EUDAMED
06950715502488 GUDID
Basic UDI-DI
69507155CAD9
Direct marketing DI
06950715572764
FDA product code
ITJ
EMDN code
Y1299 Personal mobility devices - other
GMDN term
Walker tray
Device class
Class I
Regulation number
890.3825
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06950715572764
GUDID
06950715502488

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06950715572764; FDA GUDID lists 06950715502488), so their flags are not compared.

Related devices

Category: Walker tray

Similar devices in this category

Other devices filed under PERSONAL MOBILITY DEVICES - OTHER.

Other devices from Cofoe Medical Technology Co., Ltd.

See all devices from Cofoe Medical Technology Co., Ltd. →

Properties

  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)