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Jenx PS02 1016

by Jenx Limited

Part of a family of 1,485 devices: see the family page

Ref PS02 1016

Jenx PS02 1016 is a Class I device made by Jenx Limited, registered in EUDAMED on 3 Jun 2026 (Basic UDI-DI 50562352POSTURESYSACC4F) and listed in FDA GUDID since 29 Sep 2023 (UDI-DI 05056235219873), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50562352POSTURESYSACC4F Basic UDI-DI 05056235219873UDI-DIDate3 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05056235219873 UDI-DI Date29 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 50562352POSTURESYSACC4F registered 3 Jun 2026 Active
  • FDA GUDID UDI-DI 05056235219873 listed 29 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 05056235219873
  2. Registered EUDAMED 50562352POSTURESYSACC4F

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  • Withdrawn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
LEGACY SPARE Prone Stander Size 2 Plastic Tray EUDAMED
Jenx GUDID
Generic name
Walker tray
Device name
Accessories
Model / reference
PS02 1016
Primary DI / UDI-DI
05056235219873
Basic UDI-DI
50562352POSTURESYSACC4F
FDA product code
INW
EMDN code
Y180980 Seating systems / posture systems / seating aids - accessories
GMDN term
Walker tray
Device class
Class I
Regulation number
890.3750
EU registration type
Standard device
EU market of registration
Norway
GUDID distribution status
In Commercial Distribution

Related devices

Category: Walker tray

Similar devices in this category

Other devices filed under SEATING SYSTEMS / POSTURE SYSTEMS / SEATING AIDS - ACCESSORIES.

Other devices from Jenx Limited

See all devices from Jenx Limited →

Properties

  • Reusable
  • Reprocessed single-use device
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)