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Device Explorer · FDA GUDID · GMDN 35750

Analytical non-scalp cutaneous lead

An insulated metal wire(s) designed to conduct electrical signals between a skin electrode(s) or needle electrode(s) [electrode not included] and a device designed for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (

US‑registered devices199in commercial distribution
Companies23labelers on GUDID
Single‑use17%of device records
Sterile8%labelled sterile
Prescription65%Rx‑only share
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Share of device records

Natus Neurology Incorporated5427%
Chalgren Enterprises3719%
Technomed Engineering B.V.2211%
Nox Medical Ehf.168%
Interacoustics A/S137%
Laborie Medical Technologies Corp.105%
Advanced Brain Monitoring, Inc.84%
Djo, Llc74%

Top labelers

CompanyDevicesShare
Natus Neurology Incorporated5427%
Chalgren Enterprises3719%
Technomed Engineering B.V.2211%
Nox Medical Ehf.168%
Interacoustics A/S137%
Laborie Medical Technologies Corp.105%
Advanced Brain Monitoring, Inc.84%
Djo, Llc74%
Rhythmlink International, Llc53%
Spes Medica Spa53%
R.J.L. Sciences, Inc.42%
Ambu A/S32%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Sanibel Supply A/S"Ambu Neuroline Monopolar CableLength of leadwir"Ambu Neuroline Concentric Cable,Lenght of leadw"Ambu Neuroline Concentric Cable,Lenght of leadwCHATTANOOGADynamic Lead Wire SetUrovalSeaSpineX-SeriesX-Series, X8Monitoring Lead Wires, Set of 9RochesterEtymoticViva DiagnosticRhythmlink®The Electrode Store

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

FDA product codes

CodeNameDevices
GXYElectrode, Cutaneous117
IKDCable, Electrode85
GWQFull-Montage Standard Electroencephalograph12
IKDCABLE, ELECTRODE11
JXEDevice, Nerve Conduction Velocity Measurement9
OMCReduced- Montage Standard Electroencephalograph8

GMDN & GCC registration

  • GMDN code 35750 · non‑implantable
  • Single‑use 17% · sterile 8% · Rx‑only 65% · OTC 2%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 37Length (Millimeter) · 10Length (Centimeter) · 4Width (Millimeter) · 3Length (Meter) · 2Length (Feet) · 1

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

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

199 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Analytical non-scalp cutaneous lead", from 23 companies. The largest labeler is Natus Neurology Incorporated with 27% of records.

Which FDA product codes apply?

GXY (Electrode, Cutaneous), IKD (Cable, Electrode), GWQ (Full-Montage Standard Electroencephalograph), IKD (CABLE, ELECTRODE)

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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