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Ultium Accelerometer SmartLead

by Noraxon USA, Inc.

Part of a family of 28 devices: see the family page

Ref 817

Ultium Accelerometer SmartLead (817) is a device classified as Class I in the EU and Class II in the US made by Noraxon USA, Inc., registered in EUDAMED on 6 Jan 2023 (Basic UDI-DI 081627102EMGACCYN) and listed in FDA GUDID since 30 Mar 2026 (UDI-DI 00816271020438), 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 Number00816271020438 UDI-DI Date30 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number081627102EMGACCYN Basic UDI-DI 00816271020438UDI-DIDate6 Jan 2023RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081627102EMGACCYN registered 6 Jan 2023 Active
  • FDA GUDID UDI-DI 00816271020438 listed 30 Mar 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 081627102EMGACCYN
  2. Listed FDA GUDID 00816271020438

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  • Withdrawn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 Accelerometer SmartLead EUDAMED
Ultium GUDID
Generic name
Kinesiology/electromyographic sensor set
Device name
Wireless EMG Family Accessories
Model / reference
817
Primary DI / UDI-DI
00816271020438
Basic UDI-DI
081627102EMGACCYN
FDA product code
HCC
EMDN code
Z12100480 Electromyography instruments - hardware accessories
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 ELECTROMYOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from Noraxon USA, Inc.

See all devices from Noraxon USA, Inc. →

Properties

  • Premarket exempt
  • Lot / batch number
Other properties (23, all answered No)