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Device Explorer · FDA GUDID · GMDN 61020

Analytical non-scalp cutaneous electrode

An electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoke

US‑registered devices475in commercial distribution
Companies32labelers on GUDID
Single‑use77%of device records
Sterile2%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Impulse Medical Technologies, Inc.8017%
Technomed Engineering B.V.7716%
Rhythmlink International, Llc6814%
Willowwood Global Llc6814%
Ambu A/S4610%
Natus Neurology Incorporated245%
Graphic Controls Acquisition Corp133%
Everyway Medical Instruments Co., Ltd.112%

Top labelers

CompanyDevicesShare
Impulse Medical Technologies, Inc.8017%
Technomed Engineering B.V.7716%
Rhythmlink International, Llc6814%
Willowwood Global Llc6814%
Ambu A/S4610%
Natus Neurology Incorporated245%
Graphic Controls Acquisition Corp133%
Everyway Medical Instruments Co., Ltd.112%
Neurovirtual Usa, Inc.102%
Alphatec Spine, Inc.102%
Interacoustics A/S71%
Coapt Llc71%

Company = labeler of record on GUDID. 32 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Disposable Snap Electrodes (3 pack)Disposable Snap Electrodes (25 x 3 pack)SanibelNeuroline 715Neuroline 700Neuroline GroundNeurology Surface ElectrodesZmachine Comfort 409021S02359013S02259013S02129013L0203Neuroline 710Neurology Surface ElectrodesNeuroline 720Neurology Surface ElectrodesNeuroline 715Neurology Surface ElectrodesNeuroline 700Neurology Surface ElectrodesPain Management

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GXYElectrode, Cutaneous399
GXYELECTRODE, CUTANEOUS44
GXYElectrode, cutaneous19
ETNStimulator, Nerve12
ETNSTIMULATOR, NERVE11
GWFStimulator, Electrical, Evoked Response8

GMDN & GCC registration

  • GMDN code 61020 · non‑implantable
  • Single‑use 77% · sterile 2% · Rx‑only 76% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Meter) · 79Outer Diameter (Millimeter) · 57Length (Centimeter) · 49Width (Millimeter) · 20Length (Inch) · 3Weight (Kilogram) · 2

Use these as the dimensions to specify in a tender line.

How many analytical non-scalp cutaneous electrode products are registered in the US?

475 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Analytical non-scalp cutaneous electrode", from 32 companies. The largest labeler is Impulse Medical Technologies, Inc. with 17% of records.

Which FDA product codes apply?

GXY (Electrode, Cutaneous), GXY (ELECTRODE, CUTANEOUS), GXY (Electrode, cutaneous), ETN (Stimulator, Nerve)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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