FDA.reportPublic FDA data

HEADSAFE MFG PTY LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30182385993018238599HEADSAFE MFG PTY LTD1N2026-01-0161 Marlborough St Suite 76 Surry Hills New South Wales AU 2010

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
09357225000034Nurochek-Pro - The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment of brain function. The system comprises a wearable EEG headset, associated sensors and accessories, and supporting software components. The device is intended for use by healthcare professionals in clinical environments. The kit is supplied as a complete system configuration and is not sterile.+61413133492support@team.headsafe.com
09357225000041Nurochek-Pro - The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment of brain function. The system comprises a wearable EEG headset, associated sensors and accessories, and supporting software components. The device is intended for use by healthcare professionals in clinical environments. The kit is supplied as a complete system configuration and is not sterile.+61413133492support@team.headsafe.com
09357225001017Nurochek-Pro Headset - The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potentials (SSVEP) via electroencephalography (EEG). The Nurochek-Pro headset communicates to a computer via an isolated USB-A connection, of which allows for user control of the device via a custom software Application (App). The App communicates with a cloud-based Server that stores and processes Nurochek data using a proprietary classification algorithm. The product requires internet connection to login to the application and process data.+61413133492support@team.headsafe.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2901431256018118K243426Nurochek-Pro SystemPIW2025-03-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PIW12025-03-27

GUDID#