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Eccentron LE1

by Bte Technologies, Inc.

Ref Eccentron LE1Model LE1

Eccentron LE1 is a bicycle ergometer (EU MDR Class IIa; FDA Class II; FDA product code IKK, System, Isokinetic Testing And Evaluation) made by Bte Technologies, Inc., registered in EUDAMED on 7 May 2026 (Basic UDI-DI 0850390007EccentricX4) and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 10850390007816), active as of 8 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850390007EccentricX4 Basic UDI-DI 10850390007816UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10850390007816 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850390007EccentricX4 registered 7 May 2026 Active
  • FDA GUDID UDI-DI 10850390007816 listed 25 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10850390007816
  2. Registered EUDAMED 0850390007EccentricX4

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  • Withdrawn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
Eccentron
Generic name
Bicycle ergometer
Model / reference
LE1, Eccentron LE1
Primary DI / UDI-DI
10850390007816
Basic UDI-DI
0850390007EccentricX4
Direct marketing DI
10850390007816
FDA product code
IKK
EMDN code
Z120616 Electromechanical systems for physical therapy
GMDN term
Bicycle ergometer
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.1925
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Bicycle ergometer

Similar devices in this category

Other devices filed under ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY.

Other devices from Bte Technologies, Inc.

See all devices from Bte Technologies, Inc. →

Properties

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