Australia TGA ARTG recordElectroencephalographic long-term ambulatory recorder
Australia TGA ARTG Registered Device · Compumedics Limited · Compumedics Limited · Class IIa · Started October 26, 2021
Good Name: Compumedics Limited - Electroencephalographic long-term ambulatory recorder
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- October 26, 2021
- Effective Date
- October 26, 2021
- Country
- Australia
- Address
- 30-40 Flockhart Street, ABBOTSFORD, VIC, 3067
The Okti is intended for use in the recording, display, analysis, printing and storage of the electrical activity of a patients brain or other patient biological parameters, such as heart and muscle activity, to assist in the diagnosis of various neurological disorders. Okti is designed for use in a hospital or other controlled environments. Okti is only to be used under the direction of a physician. The data acquired must be interpreted by a qualified physician.
Access comprehensive regulatory information for Electroencephalographic long-term ambulatory recorder in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Compumedics Limited, manufactured by Compumedics Limited in Australia. The device registration started on October 26, 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.