ARTG 476007Patient monitor module, electroencephalograph
ARTG ID: 476007 · Natus Medical Pty Ltd · Micromed SPA · Class IIb · Started January 17, 2025
Good Name: Natus Medical Pty Ltd - Patient monitor module, electroencephalograph
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 476007
- Start Date
- January 17, 2025
- Effective Date
- January 17, 2025
- Name
- Micromed SPA
- Country
- Italy
- Address
- Mogliano Veneto, via Giotto 2, 31021
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
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.
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