Bioelectrical signal processing application software - ARTG 468007
Access comprehensive regulatory information for Bioelectrical signal processing application software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 468007 and sponsored by Temple Healthcare Pty Ltd, manufactured by Kvikna Medical ehf in Iceland. The device registration started on November 11, 2024.
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.
Stratus EEG is an EEG system that allows acquisition, display, archive, storage and analysis of physiological signals. The intended user of this product is a qualified medical practitioner trained in electroencephalography who will exercise professional judgment in using the information. The Stratus EEG system also includes the display of quantitative EEG plots, such as power spectrum, which is intended to help the user to monitor and analyze the EEG. This device does not provide any diagnostic conclusion about the patient's condition to the user. Stratus EEG is used as an aid in the diagnosis of neurophysiological disorders such as epilepsy.