Consulting Wallah › Device Explorer › Other devices › Electroencephalographic electrode cap, single-use
Device Explorer · FDA GUDID · GMDN 17554

Electroencephalographic electrode cap, single-use

An array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap-like device with integrated

US‑registered devices65in commercial distribution
Companies6labelers on GUDID
Single‑use26%of device records
Sterile2%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Compumedics Limited4772%
Bioserenity Medical Devices Group812%
Wuhan Greentek Pty Ltd.58%
Brainscope Company, Inc.35%
Rhythmlink International, Llc12%
Prolira B.V.12%

Top labelers

CompanyDevicesShare
Compumedics Limited4772%
Bioserenity Medical Devices Group812%
Wuhan Greentek Pty Ltd.58%
Brainscope Company, Inc.35%
Rhythmlink International, Llc12%
Prolira B.V.12%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GreentekNeuronaute IceCap 2 SmallNeuronaute IceCap 2Neuronaute® IceCap Neonate (XS)Neuronaute® IceCap Neonate (S)Neuronaute® IceCap Neonate (M)Neuronaute Touchproof AdapterBaseline HeadsetElectrode HeadsetAhead Electrode HeadsetRhythmlink®Compumedics Quik-CapDeltaScan Patch

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

FDA product codes

CodeNameDevices
GXYElectrode, Cutaneous64
GXYELECTRODE, CUTANEOUS15
OLUNormalizing Quantitative Electroencephalograph Software3
PKQComputerized Cognitive Assessment Aid3
PIWBrain Injury Adjunctive Interpretive Electroencephalograph A3
GXZElectrode, Needle2

GMDN & GCC registration

  • GMDN code 17554 · non‑implantable
  • Single‑use 26% · sterile 2% · Rx‑only 100% · 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

No structured size data on the register.

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

How many electroencephalographic electrode cap, single-use products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Electroencephalographic electrode cap, single-use", from 6 companies. The largest labeler is Compumedics Limited with 72% of records.

Which FDA product codes apply?

GXY (Electrode, Cutaneous), GXY (ELECTRODE, CUTANEOUS), OLU (Normalizing Quantitative Electroencephalograph Software), PKQ (Computerized Cognitive Assessment Aid)

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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