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Device Explorer · FDA GUDID · GMDN 56641

Stereotactic neuronavigation/planning system

A mobile assembly of mains electricity (AC-powered) electronic and optical devices designed to receive and analyse patient magnetic resonance imaging (MRI) images and position landmarks manually or automatically on these images, then register the images by the

US‑registered devices113in commercial distribution
Companies10labelers on GUDID
Single‑use6%of device records
Sterile2%labelled sterile
Prescription50%Rx‑only share
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Share of device records

Brain Navi Biotechnology Co., Ltd.3531%
Eemagine Medical Imaging Solutions Gmbh2825%
Localite Gmbh2825%
Nexstim Oyj1412%
Fhc, Inc.22%
Zeta Surgical Inc.22%
Magnus Medical, Inc.11%
Compass International11%

Top labelers

CompanyDevicesShare
Brain Navi Biotechnology Co., Ltd.3531%
Eemagine Medical Imaging Solutions Gmbh2825%
Localite Gmbh2825%
Nexstim Oyj1412%
Fhc, Inc.22%
Zeta Surgical Inc.22%
Magnus Medical, Inc.11%
Compass International11%
Seaspine Orthopedics Corporation11%
Syrma Johari Medtech Limited11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Nexstim Head Tracker TapeNexstim NBS White Head TrackerNexstim NBS SystemNexstim NBT White Head TrackerNexstim NBT softwareNexstim NBT systemNexstim NBS Black Head TrackerNexstim NBS Orange Head TrackerNexstim Cooled CoilNexstim Focal CoilNexstim NBS software GERNexSpeech analyzer softwareNexSpeech main softwareInstrument Holder S SetBasic Sterilization Case SetInstrument Adaptor (7 mm)

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

FDA product codes

CodeNameDevices
HAWNeurological Stereotaxic Instrument90
HAWNeurological stereotaxic Instrument28
GWFStimulator, Electrical, Evoked Response14
IKNElectromyograph, Diagnostic14
OBPTranscranial Magnetic Stimulator6
QRISurgical planning software for neurological stereotaxic inst3

GMDN & GCC registration

  • GMDN code 56641 · non‑implantable
  • Single‑use 6% · sterile 2% · Rx‑only 50% · 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 stereotactic neuronavigation/planning system products are registered in the US?

113 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Stereotactic neuronavigation/planning system", from 10 companies. The largest labeler is Brain Navi Biotechnology Co., Ltd. with 31% of records.

Which FDA product codes apply?

HAW (Neurological Stereotaxic Instrument), HAW (Neurological stereotaxic Instrument), GWF (Stimulator, Electrical, Evoked Response), IKN (Electromyograph, Diagnostic)

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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