Consulting Wallah › Device Explorer › Syringes, needles & infusion › Subdermal needle electrode
Device Explorer · FDA GUDID · GMDN 47714

Subdermal needle electrode

A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked

US‑registered devices764in commercial distribution
Companies15labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Rhythmlink International, Llc20026%
Technomed Engineering B.V.17823%
Xi'An Friendship Medical Electronics Co.,Ltd.10113%
Medtronic Xomed, Inc.7410%
Lifesync Corporation699%
Ad-Tech Medical Instrument Corporation355%
Stryker Leibinger Gmbh & Co. Kg213%
Impulse Medical Technologies, Inc.203%

Top labelers

CompanyDevicesShare
Rhythmlink International, Llc20026%
Technomed Engineering B.V.17823%
Xi'An Friendship Medical Electronics Co.,Ltd.10113%
Medtronic Xomed, Inc.7410%
Lifesync Corporation699%
Ad-Tech Medical Instrument Corporation355%
Stryker Leibinger Gmbh & Co. Kg213%
Impulse Medical Technologies, Inc.203%
Inomed Medizintechnik Gmbh182%
Medtronic Sofamor Danek, Inc.162%
Ambu A/S152%
Alphatec Spine, Inc.71%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NANeuroline SubdermalNeurology Needle ElectrodesAmbu Subdermal CorkscrewSingle Patient ProbesNeuroline Twisted Pair SubdermalNeurology NeedleN/ACorkscew ElectrodeCorkscrew ElectrodeHorizon™SurePoint™RochesterSpinal Electrode KitSphenoidal Electrode SetRhythmlink®RHYTHMLINK INTERNATIONAL, LLCRhythmlinkThe 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
GXZElectrode, Needle721
IKTElectrode, Needle, Diagnostic Electromyograph191
GXZELECTRODE, NEEDLE82
GWFStimulator, Electrical, Evoked Response79
ETNStimulator, Nerve79
GWFSTIMULATOR, ELECTRICAL, EVOKED RESPONSE49

GMDN & GCC registration

  • GMDN code 47714 · non‑implantable
  • Single‑use 100% · sterile 96% · Rx‑only 96% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 361Outer Diameter (Millimeter) · 185Needle Gauge (Gauge) · 140Length (Meter) · 61Length (Centimeter) · 22Lumen/Inner Diameter (Millimeter) · 5

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

No closely related category with 50+ devices.

How many subdermal needle electrode products are registered in the US?

764 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Subdermal needle electrode", from 15 companies. The largest labeler is Rhythmlink International, Llc with 26% of records.

Which FDA product codes apply?

GXZ (Electrode, Needle), IKT (Electrode, Needle, Diagnostic Electromyograph), GXZ (ELECTRODE, NEEDLE), GWF (Stimulator, Electrical, Evoked Response)

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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