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Device Explorer · FDA GUDID · GMDN 37323

Patient monitoring system module, electroencephalographic

A small unit dedicated to detect and record the electrical activity of the brain in the form of an electroencephalogram (EEG). The electrical activity of the brain is detected via electrodes affixed to the patient's forehead or scalp. It is designed to operate

US‑registered devices69in commercial distribution
Companies8labelers on GUDID
Single‑use30%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Advanced Brain Monitoring, Inc.3652%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.812%
Masimo Corporation812%
Ge Healthcare Finland Oy69%
Micromed Spa46%
Spacelabs Healthcare (Washington), Inc34%
Draeger Medical Systems, Inc.23%
Philips Medizin Systeme Böblingen Gmbh23%

Top labelers

CompanyDevicesShare
Advanced Brain Monitoring, Inc.3652%
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.812%
Masimo Corporation812%
Ge Healthcare Finland Oy69%
Micromed Spa46%
Spacelabs Healthcare (Washington), Inc34%
Draeger Medical Systems, Inc.23%
Philips Medizin Systeme Böblingen Gmbh23%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

BIS Module (Package/ accessory/FDA)AG(Bis)(Package/no accessory)BIS Module(Package/no accessory)BIS module upgrade kit(with acc/child)Bispectral Index kitBIS module (w accessory kit)Shp Unit EEG PodInfinity MultiMed 12 PodEEG ModulePHILIPS EEG Parameter ModuleX-SeriesSleep ProfilerSedLineSedlineRD SedlineSedline™ Monitor

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

FDA product codes

CodeNameDevices
OMCReduced- Montage Standard Electroencephalograph38
GWQFull-Montage Standard Electroencephalograph37
MHXMONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR13
OMCReduced- montage standard electroencephalograph9
ORTBurst suppression detection software for electroencephalogra8
OLTNon-normalizing quantitative electroencephalograph software6

GMDN & GCC registration

  • GMDN code 37323 · non‑implantable
  • Single‑use 30% · sterile 0% · 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

No structured size data on the register.

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

How many patient monitoring system module, electroencephalographic products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient monitoring system module, electroencephalographic", from 8 companies. The largest labeler is Advanced Brain Monitoring, Inc. with 52% of records.

Which FDA product codes apply?

OMC (Reduced- Montage Standard Electroencephalograph), GWQ (Full-Montage Standard Electroencephalograph), MHX (MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR), 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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