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Axion 20045

by Axion USA LLC

Ref 20045

Axion 20045 is a device classified as Class I in the EU and Class II in the US made by Axion USA LLC, registered in EUDAMED on 15 May 2026 (Basic UDI-DI 426028018ELECTRODE48), cleared under FDA 510(k) K160138 on 11 Aug 2016 and listed in FDA GUDID since 5 Sep 2023 (UDI-DI 04260280180960), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K160138

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426028018ELECTRODE48 Basic UDI-DI 04260280180960UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260280180960 UDI-DI Date5 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160138 Date11 Aug 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426028018ELECTRODE48 registered 15 May 2026 Active
  • FDA 510(k) K160138 decided 11 Aug 2016 Active
  • FDA GUDID UDI-DI 04260280180960 listed 5 Sep 2023 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K160138
  2. Listed FDA GUDID 04260280180960
  3. Registered EUDAMED 426028018ELECTRODE48

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
AXION Elektroden EUDAMED
Axion GUDID
Generic name
Transcutaneous electrical stimulation electrode, reusable
Device name
Selbstklebende, wiederverwendbare Oberflächenelektrode für die Elektrostimulation
Model / reference
20045
Primary DI / UDI-DI
04260280180960
Basic UDI-DI
426028018ELECTRODE48
510(k) Number
FDA product code
GXY
EMDN code
N010201 Tens system electrodes
GMDN term
Transcutaneous electrical stimulation electrode, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1320
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.

Related devices

Category: Transcutaneous electrical stimulation electrode, reusable

Cleared under the same submission (K160138)

and 8 more cleared under K160138

Similar devices in this category

Other devices filed under TENS SYSTEM ELECTRODES.

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

  • Single use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)