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Multi-Axis 50215

by Therafin Corporation

Ref 50215

Multi-Axis 50215 is a wheelchair/chair/stander headrest (EU MDR Class I; FDA Class I; FDA product code IMS, Support, Head And Trunk, Wheelchair) made by Therafin Corporation, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 0840252950215TP) and listed in FDA GUDID since 6 Jul 2023 (UDI-DI 00840252901089), 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 Number0840252950215TP Basic UDI-DI 00840252901089UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840252901089 UDI-DI Date6 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0840252950215TP registered 5 Nov 2026 Active
  • FDA GUDID UDI-DI 00840252901089 listed 6 Jul 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840252901089
  2. Registered EUDAMED 0840252950215TP

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  • Withdrawn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
Headrest Hardware, Multi-Axis Offset. EUDAMED
Multi-Axis GUDID
Generic name
Wheelchair/chair/stander headrest
Model / Ref / Catalog
50215
Primary DI / UDI-DI
00840252901089
Basic UDI-DI
0840252950215TP
FDA product code
IMS
EMDN code
Y122499 Wheelchairs accessories - other
GMDN term
Wheelchair/chair/stander headrest
Device class
Class I
Regulation number
890.3910
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wheelchair/chair/stander headrest

Similar devices in this category

Other devices filed under WHEELCHAIR ACCESSORIES.

Other devices from Therafin Corporation

See all devices from Therafin Corporation →

Properties

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