Consulting Wallah › Device Explorer › Other devices › Analytical scalp lead
Device Explorer · FDA GUDID · GMDN 35749

Analytical scalp lead

A wire(s) intended to connect an electroencephalographic electrode(s) to an electroencephalographic system to facilitate the transmission of the electrical signals captured at the site of the electrode to the system for measuring, recording, monitoring and/or

US‑registered devices898in commercial distribution
Companies14labelers on GUDID
Single‑use12%of device records
Sterile21%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Pmt Corporation32837%
Ad-Tech Medical Instrument Corporation30334%
Electro-Cap International Inc18721%
Chalgren Enterprises263%
Intelligent Hearing Systems Corp.162%
Cortec Gmbh121%
Dixi Medical91%
Philips Medizin Systeme Böblingen Gmbh61%

Top labelers

CompanyDevicesShare
Pmt Corporation32837%
Ad-Tech Medical Instrument Corporation30334%
Electro-Cap International Inc18721%
Chalgren Enterprises263%
Intelligent Hearing Systems Corp.162%
Cortec Gmbh121%
Dixi Medical91%
Philips Medizin Systeme Böblingen Gmbh61%
Ge Healthcare Finland Oy30%
Nox Medical Ehf.30%
Wise Spa20%
Impulse Medical Technologies, Inc.10%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

AirRay® Electrode Connection Cable USNAEEG Cables and Lead SetsEEG ElectrodesSIGNUM Connection System CableTECH-ATTACH Slotted Disposable Connector BlockLightweight CABRIO CableLightweight TECH-ATTACH CableTECH-ATTACH Connection System CableFO TECH-ATTACH Connection CableTECH-ATTACH Disposable Connector BlockTECH- ATTACH Disposable Connector BlockTECH-ATTACH Disposable FO Connector BlockEntropy"Reusable Safety Snap Leads 40"" (3) for Duet/ArLinked Electrode Adaptor

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

FDA product codes

CodeNameDevices
IKDCable, Electrode382
IKDCABLE, ELECTRODE370
GXYElectrode, Cutaneous238
OMCReduced- montage standard electroencephalograph4
ORTBurst suppression detection software for electroencephalogra4
OLTNon-normalizing quantitative electroencephalograph software4

GMDN & GCC registration

  • GMDN code 35749 · non‑implantable
  • Single‑use 12% · sterile 21% · Rx‑only 97% · 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 (Inch) · 23Length (Centimeter) · 8

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

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

898 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Analytical scalp lead", from 14 companies. The largest labeler is Pmt Corporation with 37% of records.

Which FDA product codes apply?

IKD (Cable, Electrode), IKD (CABLE, ELECTRODE), GXY (Electrode, Cutaneous), OMC (Reduced- montage standard 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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