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The Electrode Store PRO-E12SAF

by Impulse Medical Technologies, Inc.

Ref PRO-E12SAF

The Electrode Store PRO-E12SAF is a device classified as Class IIa in the EU and Class II in the US made by Impulse Medical Technologies, Inc., registered in EUDAMED on 24 May 2026 (Basic UDI-DI B-00816022021233), cleared under FDA 510(k) K020910 on 19 Jul 2002 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00816022021233), active as of 24 Oct 2026.

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

CE MDD 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) K020910

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/MDD EUDAMED NumberB-00816022021233 Basic UDI-DI 00816022021233UDI-DIDate24 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816022021233 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK020910 Date19 Jul 2002DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00816022021233 registered 24 May 2026 Active
  • FDA 510(k) K020910 decided 19 Jul 2002 Active
  • FDA GUDID UDI-DI 00816022021233 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K020910
  2. Listed FDA GUDID 00816022021233
  3. Registered EUDAMED B-00816022021233

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
The Electrode Store
Generic name
Subdermal needle electrode
Device name
Disposable Sterile EEG Subdermal Needle Electrode
Model / Ref / Catalog
PRO-E12SAF
Primary DI / UDI-DI
00816022021233
Basic UDI-DI
B-00816022021233
510(k) Number
FDA product code
GXZ
EMDN code
N01010202 EEG extracranic electrodes
GMDN term
Subdermal needle electrode
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.1350
EU registration type
Legacy device (under a directive)
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: Subdermal needle electrode

Cleared under the same submission (K020910)

and 8 more cleared under K020910

Similar devices in this category

Other devices filed under EEG EXTRACRANIC ELECTRODES.

Other devices from Impulse Medical Technologies, Inc.

  • DPNCheck NC-030

    Class II

  • DPNCheck NC-040

    Class II

  • DPNCheck NC-040-C

    Class II

  • DPNCheck DB-050-C

    Class II

See all devices from Impulse Medical Technologies, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)