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Axion 20127

by Axion USA LLC

Ref 20127

Axion 20127 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 9 Apr 2025 (UDI-DI 04260280181929), 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 linked in EUDAMED

A group certificate may exist

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 04260280181929UDI-DIDate15 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260280181929 UDI-DI Date9 Apr 2025ListedStatusListed 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 04260280181929 listed 9 Apr 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K160138
  2. Listed FDA GUDID 04260280181929
  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  • Withdrawn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
20127
Primary DI / UDI-DI
04260280181929
Basic UDI-DI
426028018ELECTRODE48
Unit of use DI
04260280187297
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

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