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Armeo Support Harness

by Hocoma AG

Ref 62644

Armeo Support Harness (62644) is a device classified as Class I in the EU and Class II in the US made by Hocoma AG, registered in EUDAMED on 30 May 2024 (Basic UDI-DI 764017466ASHLB) and listed in FDA GUDID since 11 Oct 2023 (UDI-DI 07640174660391), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 Number764017466ASHLB Basic UDI-DI 07640174660391UDI-DIDate30 May 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number07640174660391 UDI-DI Date11 Oct 2023ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764017466ASHLB registered 30 May 2024 Active
  • FDA GUDID UDI-DI 07640174660391 listed 11 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640174660391
  2. Registered EUDAMED 764017466ASHLB

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  • Withdrawn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
Armeo Support Harness EUDAMED
Armeo GUDID
Generic name
Wheelchair/chair/stander occupant restraint/support
Model / Ref / Catalog
62644, Support Harness
Primary DI / UDI-DI
07640174660391
Basic UDI-DI
764017466ASHLB
Direct marketing DI
07640174660391
FDA product code
IKK
EMDN code
N01028099 Neurological physiotherapy devices - accessories - other
GMDN term
Wheelchair/chair/stander occupant restraint/support
Device class
Class I EUDAMED
Class II GUDID
Regulation number
890.1925
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
62644
GUDID
Support Harness
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
CH-MF-000014672
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)