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Leggero Enzo

by Altimate Medical, Inc.

Ref 3101Model ENZO™ SE Side-Fold (3101-0200), ENZO™ SE Rigid (3101-0002), ENZO™ Side-Fold (3101-0201), and ENZO™ Rigid (3101-0001)

Leggero Enzo (3101) is an attendant-only-propelled wheelchair (EU MDR Class I; FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Altimate Medical, Inc., registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 108589210063101E5), cleared under FDA 510(k) K182840 on 29 Apr 2019 and listed in FDA GUDID since 18 Aug 2026 (UDI-DI 10858921006239), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182840

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number108589210063101E5 Basic UDI-DI 10858921006239UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10858921006239 UDI-DI Date18 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182840 Date29 Apr 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 108589210063101E5 registered 22 Oct 2026 Active
  • FDA 510(k) K182840 decided 29 Apr 2019 Active
  • FDA GUDID UDI-DI 10858921006239 listed 18 Aug 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K182840
  2. Listed FDA GUDID 10858921006239
  3. Registered EUDAMED 108589210063101E5

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Enzo EUDAMED
Leggero GUDID
Generic name
Attendant-only-propelled wheelchair, non-bariatric
Model / Ref / Catalog
ENZO™ SE Side-Fold (3101-0200), ENZO™ SE Rigid (3101-0002), ENZO™ Side-Fold (3101-0201), and ENZO™ Rigid (3101-0001), 3101, Enzo
Primary DI / UDI-DI
10858921006239
Basic UDI-DI
108589210063101E5
510(k) Number
FDA product code
IOR
EMDN code
Y122103 Push wheelchairs
GMDN term
Attendant-only-propelled wheelchair, non-bariatric
Device class
Class I
Regulation number
890.3850
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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Properties

  • Over-the-counter
  • Serial number
Other properties (23, all answered No)