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The Electrode Store 1023(2)

by Impulse Medical Technologies, Inc.

Ref 1023-KModel Disposable Cutaneous Surface Electrode

Listed No authorization on record

CE, no status data

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816022020878 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
The Electrode Store
Generic Name
Analytical non-scalp cutaneous electrode
Device Name
Disposable Cutaneous Surface Electrode
Model / Ref / Catalog
Disposable Cutaneous Surface Electrode EUDAMED
1023-K EUDAMED
1023(2) GUDID
Primary DI / UDI-DI
00816022020878
Basic UDI-DI
081602202SURFDI74
Direct Marketing DI
00816022020878
510(k) Number
FDA Product Code
GXY
EMDN Code
N010101 Electromyographic electrodes
GMDN Term
Analytical non-scalp cutaneous electrode
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
882.1320
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Disposable Cutaneous Surface Electrode
1023-K
GUDID
1023(2)
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K020445)

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Properties

  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No