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Leggero Trak

by Altimate Medical, Inc.

Ref 3002Model TRAK™ 12 (3002-1003), TRAK™ 14 (3002-1001), TRAK SE™ 12 (3002-1004), and TRAK SE™ 14 (3002-1002).

Leggero Trak (3002) is a Class I device made by Altimate Medical, Inc., registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 108589210063002E2) and listed in FDA GUDID since 18 Aug 2026 (UDI-DI 10858921006253), 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 Number108589210063002E2 Basic UDI-DI 10858921006253UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10858921006253 UDI-DI Date18 Aug 2026ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 108589210063002E2 registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 10858921006253 listed 18 Aug 2026 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10858921006253
  2. Registered EUDAMED 108589210063002E2

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  • Withdrawn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
Trak EUDAMED
Leggero GUDID
Generic name
Assistive pushchair
Model / Ref / Catalog
TRAK™ 12 (3002-1003), TRAK™ 14 (3002-1001), TRAK SE™ 12 (3002-1004), and TRAK SE™ 14 (3002-1002)., 3002, Trak
Primary DI / UDI-DI
10858921006253
Basic UDI-DI
108589210063002E2
FDA product code
INM
EMDN code
Y122703 Pushchairs
GMDN term
Assistive pushchair
Device class
Class I
Regulation number
890.3100
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

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Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)