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Motion composites Helio C2

by Motion Composites

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

Ref Helio C2

Motion composites Helio C2 is a wheelchair (EU MDR Class I; FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Motion Composites, registered in EUDAMED on 13 May 2026 (Basic UDI-DI 81177400MCMANUALWC2020FH) and listed in FDA GUDID since 24 Sep 2022 (UDI-DI 00811774000031), 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 Number81177400MCMANUALWC2020FH Basic UDI-DI 00811774000031UDI-DIDate13 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00811774000031 UDI-DI Date24 Sep 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 81177400MCMANUALWC2020FH registered 13 May 2026 Active
  • FDA GUDID UDI-DI 00811774000031 listed 24 Sep 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00811774000031
  2. Registered EUDAMED 81177400MCMANUALWC2020FH

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  • Withdrawn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
Motion composites
Generic name
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Device name
Manual Wheelchairs
Model / reference
Helio C2
Primary DI / UDI-DI
00811774000031
Basic UDI-DI
81177400MCMANUALWC2020FH
Direct marketing DI
00811774000031
FDA product code
IOR
EMDN code
Y122103 Push wheelchairs
GMDN term
Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible
Device class
Class I
Regulation number
890.3850
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wheelchair, attendant/occupant-driven, rear-wheels-operated, collapsible

Similar devices in this category

Other devices filed under PUSH WHEELCHAIRS.

Other devices from Motion Composites

See all devices from Motion Composites →

Properties

Other properties (25, all answered No)