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MCU Multi-Cervical Unit MCU 2

by Bte Technologies, Inc.

Ref MCU 2

MCU Multi-Cervical Unit MCU 2 is a neck mechanical weight exerciser (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 0850390007MultiCervicalGU) and listed in FDA GUDID since 25 Aug 2016 (UDI-DI 10850390007427), 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 Number0850390007MultiCervicalGU Basic UDI-DI 10850390007427UDI-DIDate7 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10850390007427 UDI-DI Date25 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850390007MultiCervicalGU registered 7 May 2026 Active
  • FDA GUDID UDI-DI 10850390007427 listed 25 Aug 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10850390007427
  2. Registered EUDAMED 0850390007MultiCervicalGU

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  • Withdrawn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
MCU Multi-Cervical Unit
Generic name
Neck mechanical weight exerciser
Device name
MCU - Multi Cervical Unit
Model / reference
MCU 2
Primary DI / UDI-DI
10850390007427
Basic UDI-DI
0850390007MultiCervicalGU
Direct marketing DI
10850390007427
FDA product code
IKK
EMDN code
Z120616 Electromechanical systems for physical therapy
GMDN term
Neck mechanical weight exerciser
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
890.1925
EU registration type
Standard device
EU market of registration
Spain
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: Neck mechanical weight exerciser

Similar devices

Also classified as Neck mechanical weight exerciser.

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)