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Spex 1401-6166-017

by Spex Limited

Part of a family of 23 devices: see the family page

Ref 1401-6166-017

Spex 1401-6166-017 is a Class I device made by Spex Limited, registered in EUDAMED on 3 May 2026 (Basic UDI-DI 94200517LIMBSTABILISERVW) and listed in FDA GUDID since 12 Dec 2022 (UDI-DI 09420051701267), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number94200517LIMBSTABILISERVW Basic UDI-DI 09420051701267UDI-DIDate3 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09420051701267 UDI-DI Date12 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 94200517LIMBSTABILISERVW registered 3 May 2026 Active
  • FDA GUDID UDI-DI 09420051701267 listed 12 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 09420051701267
  2. Registered EUDAMED 94200517LIMBSTABILISERVW

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  • Withdrawn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
Spex
Generic name
Wheelchair/chair/stander occupant restraint/support
Device name
Upper and Lower Limb Stabilisers
Model / Ref / Catalog
1401-6166-017
Primary DI / UDI-DI
09420051701267
Basic UDI-DI
94200517LIMBSTABILISERVW
Direct marketing DI
09420051701267
FDA product code
KNO
EMDN code
Y122403 Wheelchair footrests, supports and controls
GMDN term
Wheelchair/chair/stander occupant restraint/support
Device class
Class I
Regulation number
890.3910
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wheelchair/chair/stander occupant restraint/support

Similar devices in this category

Other devices filed under WHEELCHAIR FOOTRESTS, SUPPORTS AND CONTROLS.

Other devices from Spex Limited

See all devices from Spex Limited →

Properties

  • Premarket exempt
Other properties (24, all answered No)