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Lexo R1

by tyromotion GmbH

Lexo R1 is a Class II device made by tyromotion GmbH, registered in EUDAMED and listed in FDA GUDID since 30 Sep 2021 (UDI-DI 09120077180076), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number09120077180076 UDI-DI Date30 Sep 2021ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 09120077180076 listed 30 Sep 2021 Listed

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  • Withdrawn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
Lexo
Generic name
Treadmill/elliptical gait rehabilitation system
Model / reference
R1
Primary DI / UDI-DI
09120077180076
FDA product code
IKK
GMDN term
Treadmill/elliptical gait rehabilitation system
Device class
Class II
Regulation number
890.1925
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IKK (System, Isokinetic Testing And Evaluation).

Other devices from tyromotion GmbH

See all devices from tyromotion GmbH →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)