Consulting Wallah › Device Explorer › Other devices › Electroencephalograph
Device Explorer · FDA GUDID · GMDN 11467

Electroencephalograph

An electrically-powered device designed for noninvasive recording of the electrical activity of the brain for display in the form of a graph [electroencephalogram (EEG)], typically to study a variety of neurological conditions, evaluate psychiatric disorders,

US‑registered devices575in commercial distribution
Companies36labelers on GUDID
Single‑use5%of device records
Sterile10%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Xltek10118%
Nihon Kohden America, Inc.6712%
Advanced Brain Monitoring, Inc.6111%
Nihon Kohden Corporation5510%
Compumedics Limited427%
Cadwell Industries, Inc.356%
Cleveland Medical Devices Inc.275%
Natus Neurology Incorporated265%

Top labelers

CompanyDevicesShare
Xltek10118%
Nihon Kohden America, Inc.6712%
Advanced Brain Monitoring, Inc.6111%
Nihon Kohden Corporation5510%
Compumedics Limited427%
Cadwell Industries, Inc.356%
Cleveland Medical Devices Inc.275%
Natus Neurology Incorporated265%
Zeto, Inc.214%
Eb Neuro Spa193%
Megin Oy183%
Medimax Tech Inc.183%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TRIUX™ neoTRIUX™ neo bedTRIUX™ neo chairPediatric comfort setSEF electrode assembly128-channel EEG cap (L)128-channel EEG cap (M)64-channel EEG cap (L)64-channel EEG cap (M)64-channel EEG cap (S)Head position coil setBilateral finger response systemAuditory stimulator (earphones)Patient couchPatient chairMaxFilter™ 2.2

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

FDA product codes

CodeNameDevices
GWQFull-Montage Standard Electroencephalograph283
OLTNon-normalizing quantitative electroencephalograph software90
OMCReduced- Montage Standard Electroencephalograph78
OLVStandard polysomnograph with electroencephalograph71
OLVStandard Polysomnograph With Electroencephalograph71
GWQFull-montage Standard Electroencephalograph65

GMDN & GCC registration

  • GMDN code 11467 · non‑implantable
  • Single‑use 5% · sterile 10% · Rx‑only 93% · 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 (Centimeter) · 5Width (Centimeter) · 5Height (Centimeter) · 4Weight (Gram) · 3Length (Meter) · 2

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No closely related category with 50+ devices.

How many electroencephalograph products are registered in the US?

575 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electroencephalograph", from 36 companies. The largest labeler is Xltek with 18% of records.

Which FDA product codes apply?

GWQ (Full-Montage Standard Electroencephalograph), OLT (Non-normalizing quantitative electroencephalograph software), OMC (Reduced- Montage Standard Electroencephalograph), OLV (Standard polysomnograph with electroencephalograph)

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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