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Advanced Bath Chair

by James Leckey Design Ltd

Ref LAB

Advanced Bath Chair (LAB) is a shower seat (EU MDR Class I; FDA Class I; FDA product code ILS, Adaptor, Hygiene) made by James Leckey Design Ltd, registered in EUDAMED on 26 May 2022 (Basic UDI-DI 05059804104Bathing7L) and listed in FDA GUDID since 7 Oct 2023 (UDI-DI 05059804500006), 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
United StatesGUDID listing GUDID Number05059804500006 UDI-DI Date7 Oct 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number05059804104Bathing7L Basic UDI-DI 05059804500006UDI-DIDate26 May 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 05059804104Bathing7L registered 26 May 2022 Active
  • FDA GUDID UDI-DI 05059804500006 listed 7 Oct 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 05059804104Bathing7L
  2. Listed FDA GUDID 05059804500006

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  • Withdrawn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
Advanced Bath Chair EUDAMED
Leckey Advanced Bath Chair GUDID
Generic name
Shower seat, non-powered
Device name
Bathing
Model / reference
LAB EUDAMED
Advanced Bath Chair GUDID
Primary DI / UDI-DI
05059804500006
Basic UDI-DI
05059804104Bathing7L
Direct marketing DI
05059804500006
FDA product code
ILS
EMDN code
Y093399 Washing, bathing and showering devices - other
GMDN term
Shower seat, non-powered
Device class
Class I
Regulation number
890.5050
EU registration type
Standard device
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
LAB
GUDID
Advanced Bath Chair

Manufacturer details

EUDAMED SRN
XI-MF-000003572

Related devices

Category: Hydrotherapy bath/tank

Similar devices in this category

Other devices filed under WASHING, BATHING AND SHOWERING DEVICES - OTHER.

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Properties

  • Premarket exempt
  • Manufacturing date
Other properties (23, all answered No)