Intra Operative Monitor - Neurophysiologic monitoring system - ARTG 392670
Access comprehensive regulatory information for Intra Operative Monitor - Neurophysiologic monitoring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 392670 and sponsored by AIMedical International Pty Ltd, manufactured by Neurosoft LLC in Russia. The device registration started on July 25, 2022.
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.
Neuro-IOM system with Neuro-IOM.NET software is a medical device intended for intraoperative neurophysiologic monitoring: the device provides information to assess a patient’s neurophysiological status. The system allows to monitor the functional integrity and/or mapping of central and peripheral nervous system including motor and sensory pathways. It is provided in III different configurations: I. 32/B II. 32/S III. 16/S The system ensures the following IOM modalities: free-run EMG (electromyography), direct nerve stimulation including pedicle screw test, SSEP (somatosensory evoked potentials), MEP (motor evoked potentials), EEG (electroencephalography), AEP (auditory evoked potentials), VEP (visual evoked potentials), direct cortical stimulation. Also, the train-of-four (TOF) stimulation is performed. The system is not intended to measure the vital signs. It records the data to be interpreted by the neuromonitoring specialist.