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Ultium EMG Sensor

by Noraxon USA, Inc.

Ref 810

Ultium EMG Sensor (810) is a kinesiology/electromyographic sensor set (EU MDR Class I; FDA Class II; FDA product code HCC, Device, Biofeedback) made by Noraxon USA, Inc., registered in EUDAMED on 6 Jan 2023 (Basic UDI-DI 081627102EMGC7) and listed in FDA GUDID since 6 Nov 2019 (UDI-DI 00816271020223), 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
European UnionCE/MDR EUDAMED Number081627102EMGC7 Basic UDI-DI 00816271020223UDI-DIDate6 Jan 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00816271020223 UDI-DI Date6 Nov 2019ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081627102EMGC7 registered 6 Jan 2023 Active
  • FDA GUDID UDI-DI 00816271020223 listed 6 Nov 2019 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816271020223
  2. Registered EUDAMED 081627102EMGC7

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  • Withdrawn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
Ultium EMG Sensor EUDAMED
Ultium GUDID
Generic name
Kinesiology/electromyographic sensor set
Device name
Wireless EMG Family
Model / reference
810
Primary DI / UDI-DI
00816271020223
Basic UDI-DI
081627102EMGC7
Direct marketing DI
00816271020223
FDA product code
HCC
EMDN code
Z12100401 Electromyographs
GMDN term
Kinesiology/electromyographic sensor set
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
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 I
GUDID
Class II

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

Manufacturer details

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

Similar devices in this category

Other devices filed under ELECTROMYOGRAPHS.

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Properties

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