Nurochek-Pro HS03-369

GUDID 09357225000041

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.

HEADSAFE MFG PTY LTD

Evoked-potential graphic recording system

• Primary Device ID: 09357225000041
• NIH Device Record Key: 32de2f26-ab43-4962-a3a6-44777acf4317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nurochek-Pro
• Version Model Number: Nurochek-Pro Kit (HS03-369) rev 2
• Catalog Number: HS03-369
• 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: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• 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
• 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
• Phone: +61413133492
• Email: support@team.headsafe.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 620 millibar and 1060 millibar
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	09357225000034 [Previous]
GS1	09357225000041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243426

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

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: 2026-02-02
• Device Publish Date: 2026-01-23

On-Brand Devices [Nurochek-Pro]

• 09357225000034: The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment
• 09357225000041: The Nurochek-Pro Kit is a non-invasive medical device system intended to support the assessment