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The Electrode Store DDB-30BSAF

by Impulse Medical Technologies, Inc.

Ref DDB-30BSAFModel Reusable 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 linked in EUDAMED

A group certificate may exist

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 Number00816022022469 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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
Reusable Cutaneous Surface Electrode
Model / Ref / Catalog
DDB-30BSAF, Reusable Cutaneous Surface Electrode
Primary DI / UDI-DI
00816022022469
Basic UDI-DI
081602202SURFRU96
Direct Marketing DI
00816022022469
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 · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Related devices

Cleared under the same submission (K020445)

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Other devices from Impulse Medical Technologies, Inc.

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Properties

  • Lot / Batch Number
  • Manufacturing Date

Other properties (22)

  • Sterile: No
  • Single Use: 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
  • Expiration Date: No