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Electroencephalographic long-term ambulatory recorder

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.

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Class IIa
Class IIa
Electroencephalographic long-term ambulatory recorder
Australia TGA ARTG Registered Device
Good Name: Compumedics Limited - Electroencephalographic long-term ambulatory recorder
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Intended Purpose

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.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
October 26, 2021
Effective Date
October 26, 2021
Manufacturer
Country
Australia
Address
30-40 Flockhart Street, ABBOTSFORD, VIC, 3067