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Axion 1023

by Axion USA LLC

Ref 1023

Axion 1023 is a device classified as Class IIa in the EU and Class II in the US made by Axion USA LLC, registered in EUDAMED on 15 May 2026 (Basic UDI-DI 426028018TENS9B) and listed in FDA GUDID since 11 May 2024 (UDI-DI 04260280181318), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426028018TENS9B Basic UDI-DI 04260280181318UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260280181318 UDI-DI Date11 May 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426028018TENS9B registered 15 May 2026 Active
  • FDA GUDID UDI-DI 04260280181318 listed 11 May 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260280181318
  2. Registered EUDAMED 426028018TENS9B

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  • Withdrawn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
STIM-PRO Comfort+ EUDAMED
Axion GUDID
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Device name
AXION TENS Devices
Model / reference
1023
Primary DI / UDI-DI
04260280181318
Basic UDI-DI
426028018TENS9B
Direct marketing DI
04260280181318
FDA product code
GZJ
EMDN code
Z120601 Electrotherapy equipment (included tens)
GMDN term
Analgesic transcutaneous electrical nerve stimulation system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.5890
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: Analgesic transcutaneous electrical nerve stimulation system

Similar devices in this category

Other devices filed under ELECTROTHERAPY EQUIPMENT (INCLUDED TENS).

Other devices from Axion USA LLC

  • Axion 20139

    Class II

  • Axion 327006

    Class I

  • Axion 328008

    Class I

  • Axion 20114

    Class II

See all devices from Axion USA LLC →

Properties

  • Over-the-counter
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)