Skip to content

Axion 328007

by Axion USA LLC

Ref 328007

Axion 328007 is a Class I device made by Axion USA LLC, registered in EUDAMED on 21 Oct 2026 (Basic UDI-DI 426028018FLEXTAPES6) and listed in FDA GUDID since 26 Oct 2023 (UDI-DI 04260280185538), 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 Number426028018FLEXTAPES6 Basic UDI-DI 04260280185538UDI-DIDate21 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260280185538 UDI-DI Date26 Oct 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 426028018FLEXTAPES6 registered 21 Oct 2026 Active
  • FDA GUDID UDI-DI 04260280185538 listed 26 Oct 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04260280185538
  2. Registered EUDAMED 426028018FLEXTAPES6

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  • Withdrawn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 FlexTape EUDAMED
Axion GUDID
Generic name
Adhesive bandage
Model / reference
328007
Primary DI / UDI-DI
04260280185538
Basic UDI-DI
426028018FLEXTAPES6
Unit of use DI
04260280186450
FDA product code
KGX
EMDN code
M030402030102 Elastic support bandages, adhesive extensible in one direction, high extensibility
GMDN term
Adhesive bandage
Device class
Class I
Regulation number
880.5240
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Adhesive bandage

Similar devices in this category

Other devices filed under ELASTIC SUPPORT BANDAGES, ADHESIVE EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY.

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
  • Premarket exempt
Other properties (23, all answered No)