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myoRESEARCH - myoMOTION Software Module

by Noraxon USA, Inc.

Ref 405

myoRESEARCH - myoMOTION Software Module (405) is a Class I device made by Noraxon USA, Inc., registered in EUDAMED on 6 Jan 2023 (Basic UDI-DI 081627102IMUDP) and listed in FDA GUDID since 7 Jun 2023 (UDI-DI 00816271020742), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816271020742 UDI-DI Date7 Jun 2023ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081627102IMUDP Basic UDI-DI 00816271020742UDI-DIDate6 Jan 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081627102IMUDP registered 6 Jan 2023 Active
  • FDA GUDID UDI-DI 00816271020742 listed 7 Jun 2023 Listed

Timeline

2 dated events

  1. Registered EUDAMED 081627102IMUDP
  2. Listed FDA GUDID 00816271020742

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  • Withdrawn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
myoRESEARCH - myoMOTION Software Module EUDAMED
myoRESEARCH GUDID
Generic name
Biomechanical function analysis/rehabilitation software
Device name
Wireless IMU Family
Model / Ref / Catalog
405
Primary DI / UDI-DI
00816271020742
Basic UDI-DI
081627102IMUDP
Direct marketing DI
00816271020742
FDA product code
KQX
EMDN code
Z12100492 Electromyography instruments -medical device software
GMDN term
Biomechanical function analysis/rehabilitation software
Device class
Class I
Regulation number
888.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000003882
Authorised representative
Advena Limited MT-AR-000000234

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Properties

  • Measuring function
  • Premarket exempt
  • Serial number
Other properties (22, all answered No)