Patient monitor module, electroencephalograph - ARTG 476007
Access comprehensive regulatory information for Patient monitor module, electroencephalograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 476007 and sponsored by Natus Medical Pty Ltd, manufactured by Micromed SPA in Italy. The device registration started on January 17, 2025.
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.
SD devices are intended to acquire scalp and intracranial electroencephalographic (EEG) signals and polysomnographic (PSG) signals and they are able to manage the cortical stimulation of the patient. Electroencephalography and Polysomnography consist in the recording of electrical activity of the brain, together with other physiological parameters, and they can be used for neurophysiological studies and analysis, as diagnostic aid for the evaluation of disturbances of the functions of the Central Nervous System. When a cortical stimulator is used, the devices can be also used as help in the preliminary or intraoperative localization of the intervention sites for epilepsy surgery (stereoEEG). In order to display and analyse the recorded signals, the device must work in combination with Micromed BRAIN QUICK Software (or equivalent). The devices do not make any judgment of normality or abnormality from displayed signals or the result of an analysis. None of the functions of the devices are considered in themselves diagnostic