Nurochek-Pro Application

GUDID 09357225002021

The Nurochek-Pro Application (app) Software is a Windows desktop application that acts as the primary graphical user interface (GUI) for the user to control and communicate with the Nurochek-Pro Headset (HS03-267); both of which are components of the Nurochek-Pro System (HS03-369).

HEADSAFE MFG PTY LTD

Evoked-potential graphic recording system

• Primary Device ID: 09357225002021
• NIH Device Record Key: a780a206-b618-415c-a53d-f9c969b9f8fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nurochek-Pro Application
• Version Model Number: Nurochek-Pro Application (HS03-303)
• Company DUNS: 748905226
• Company Name: HEADSAFE MFG PTY LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +61413133492
• Email: support@team.headsafe.com
• Phone: +61413133492
• Email: support@team.headsafe.com
• Phone: +61413133492
• Email: support@team.headsafe.com
• Phone: +61413133492
• Email: support@team.headsafe.com
• Phone: +61413133492
• Email: support@team.headsafe.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09357225002021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243426

FDA Product Code

• PIW: Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-23
• Device Publish Date: 2025-12-15

Devices Manufactured by HEADSAFE MFG PTY LTD

• 09357225000034 - Nurochek-Pro: 2025-12-23 The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment of brain function. The system co
• 09357225001017 - Nurochek-Pro Headset: 2025-12-23 The Nurochek-Pro System is a medical device that consist of a headset that evokes and records steady-state visual-evoked potenti
• 09357225002021 - Nurochek-Pro Application: 2025-12-23The Nurochek-Pro Application (app) Software is a Windows desktop application that acts as the primary graphical user interface (GUI) for the user to control and communicate with the Nurochek-Pro Headset (HS03-267); both of which are components of the Nurochek-Pro System (HS03-369).
• 09357225002021 - Nurochek-Pro Application: 2025-12-23 The Nurochek-Pro Application (app) Software is a Windows desktop application that acts as the primary graphical user interface (
• 09357225002038 - Nurochek-Pro Server: 2025-12-23 The Nurochek-Pro Server is an umbrella term for backend software of the Nurochek-Pro System (HS03-369). It provides the function
• 09357225003028 - Nurochek-Pro Soft Sensor Kit: 2025-12-23 The Nurochek-Pro Soft Sensor Kit is a non-invasive accessory intended for use with the Nurochek-Pro headset. The kit contains so
• 09357225006029 - Nurochek-Pro Saline Solution: 2025-12-23 The Nurochek-Pro Saline Solution is a non-sterile accessory intended for use with the Nurochek-Pro medical device system. The so