Consulting Wallah › Device Explorer › Syringes, needles & infusion › Electromyographic needle electrode, single-use
Device Explorer · FDA GUDID · GMDN 11441

Electromyographic needle electrode, single-use

A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connecte

US‑registered devices978in commercial distribution
Companies22labelers on GUDID
Single‑use92%of device records
Sterile85%labelled sterile
Prescription70%Rx‑only share
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Share of device records

Spes Medica Spa23924%
Technomed Engineering B.V.16317%
Natus Manufacturing Limited647%
Natus Neurology Incorporated525%
Inomed Medizintechnik Gmbh505%
Cadwell Industries, Inc.485%
Chalgren Enterprises424%
Bio Protech Usa, Inc.414%

Top labelers

CompanyDevicesShare
Spes Medica Spa23924%
Technomed Engineering B.V.16317%
Natus Manufacturing Limited647%
Natus Neurology Incorporated525%
Inomed Medizintechnik Gmbh505%
Cadwell Industries, Inc.485%
Chalgren Enterprises424%
Bio Protech Usa, Inc.414%
Impulse Medical Technologies, Inc.384%
Medimax Tech Inc.374%
Rhythmlink International, Llc374%
Ambu A/S333%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ambu® Neuroline Monopolar202257-000 Needle, Mono Kit Ambu CA CEAmbu Concentric ProbeSingle Patient ProbesAmbu Bipolar ProbeSingle Patient ProbesAmbu Monopolar ProbeSingle Patient ProbesAmbu Pedicle Screw ProbeSingle Patient ProbesConcentric KitNeuroline InojectNeurology Needle ElectrodesNeuroline MonopolarNeurology Needle ElectrodesNeuroline ConcentricNeurology Needle ElectrodesN/APULSENVJJBNANVM5Twisted Pair Needle Electrode

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

FDA product codes

CodeNameDevices
IKTElectrode, Needle, Diagnostic Electromyograph627
GXZElectrode, Needle414
GWFStimulator, Electrical, Evoked Response72
GXZELECTRODE, NEEDLE66
ETNStimulator, Nerve64
GXYElectrode, Cutaneous57

GMDN & GCC registration

  • GMDN code 11441 · non‑implantable
  • Single‑use 92% · sterile 85% · Rx‑only 70% · 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

Needle Gauge (Gauge) · 242Length (Millimeter) · 225Outer Diameter (Millimeter) · 177Length (Inch) · 45Length (Meter) · 27Lumen/Inner Diameter (Millimeter) · 22

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

No closely related category with 50+ devices.

How many electromyographic needle electrode, single-use products are registered in the US?

978 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electromyographic needle electrode, single-use", from 22 companies. The largest labeler is Spes Medica Spa with 24% of records.

Which FDA product codes apply?

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

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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