Australia TGA ARTG recordEye-tracking brain injury assessment device
Australia TGA ARTG Registered Device · TBI diagnostics Pty Ltd · Oculogia Inc · Class IIa · Started April 19, 2021
Good Name: TBI diagnostics Pty Ltd - Eye-tracking brain injury assessment device
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- April 19, 2021
- Effective Date
- April 19, 2021
- Name
- Oculogia Inc
- Country
- United States of America
- Address
- 33 Irving Place, New York, New York, 10003
The EyeBOX is intended to measure and analyze eye movements as an aid in the diagnosis of concussion within one week of head injury in patients 5 through 67 years of age in conjunction with a standard neurological assessment of concussion. A negative EyeBOX classification may correspond to eye movement that is consistent with a lack of concussion. A positive EyeBOX classification corresponds to eye movement that may be present in both patients with or without concussion.
Access comprehensive regulatory information for Eye-tracking brain injury assessment device in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by TBI diagnostics Pty Ltd, manufactured by Oculogia Inc in United States of America. The device registration started on April 19, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.