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Andago

by Hocoma AG

Ref 31585

Andago (31585) is a device classified as Class IIa in the EU and Class I in the US made by Hocoma AG, registered in EUDAMED on 28 Jul 2025 (Basic UDI-DI 764017466ANUM) and listed in FDA GUDID since 22 Aug 2016 (UDI-DI 07640174660230), 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 Number764017466ANUM Basic UDI-DI 07640174660230UDI-DIDate28 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07640174660230 UDI-DI Date22 Aug 2016ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 764017466ANUM registered 28 Jul 2025 Active
  • FDA GUDID UDI-DI 07640174660230 listed 22 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 07640174660230
  2. Registered EUDAMED 764017466ANUM

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  • Withdrawn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

Generic name
Mobile gait rehabilitation system, harness-support
Device name
Andago V2.0
Model / Ref / Catalog
31585, V2.0
Primary DI / UDI-DI
07640174660230
Basic UDI-DI
764017466ANUM
FDA product code
BXB
EMDN code
N010299 Neurologic physiotheraphy devices - other
GMDN term
Mobile gait rehabilitation system, harness-support
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
890.5380
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
31585
GUDID
V2.0
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I 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
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)