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Axion 20064

by Axion USA LLC

Ref 20064

Axion 20064 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 23 Oct 2026 (Basic UDI-DI 426028018Gel-SprayA6), cleared under FDA 510(k) K222770 on 13 Dec 2022 and listed in FDA GUDID since 18 Mar 2024 (UDI-DI 04260280180335), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222770

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426028018Gel-SprayA6 Basic UDI-DI 04260280180335UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260280180335 UDI-DI Date18 Mar 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK222770 Date13 Dec 2022IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426028018Gel-SprayA6 registered 23 Oct 2026 Active
  • FDA 510(k) K222770 decided 13 Dec 2022 Active
  • FDA GUDID UDI-DI 04260280180335 listed 18 Mar 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222770
  2. Listed FDA GUDID 04260280180335
  3. Registered EUDAMED 426028018Gel-SprayA6

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  • Withdrawn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
Elektroden Kontaktgel EUDAMED
Axion GUDID
Generic name
Electrode conductive medium
Device name
Elektroden Kontaktgel / Kontaktspray
Model / reference
20064
Primary DI / UDI-DI
04260280180335
Basic UDI-DI
426028018Gel-SprayA6
510(k) Number
FDA product code
GYB
EMDN code
V9015 Electrodes and probes cutaneous conductive substances
GMDN term
Electrode conductive medium
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1275
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: Electrode conductive medium

Cleared under the same submission (K222770)

and 4 more cleared under K222770

Similar devices in this category

Other devices filed under VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES.

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
Other properties (22, all answered No)