Single-patient physiologic monitoring system
Access comprehensive regulatory information for Single-patient physiologic monitoring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Wiselink Group Pty Ltd, manufactured by Shenzhen Comen Medical Instruments Co Ltd in China. The device registration started on April 29, 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.
N10/N10A/N10C/N12/N12A/N12C/N15/N15A/N15C;N10M/N10MA/N10MC/N12M/N12MA/N12MC/N15M/N15MA/N15MC;N10MPro/N10MAPro/N12MPro/N12MAPro/N15MPro/N15MAPro is a multi-parameter monitoring device for providing a reliable reference for clinical diagnosis so that doctors can take appropriate measures timely. This monitor is mainly used to monitor the patientโs ECG (3-lead, 5-lead, 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis and Heart Rate (HR)),Respiration rate(Resp), Temperature(Temp), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Carbon Dioxide (CO2)๏ผMasimo Rainbow SpO2, Oxygen (O2) and Anesthesia gas (AG), Bispectral Index (BIS), Impedance Cardiograph (ICG), Respiration Mechanics (RM) and Neuromuscular Transmission Monitoring (NMT). It alarms when patientโs physiological parameters are overrange, and it can display, record and store each patient data and the corresponding waveforms. Usually it is used in general care (General), surgery/anesthesia care (OR), intensive care unit (ICU), neonatal care unit (Neo) and cardiac care unit (CCU). All the parameters can be monitored on single adult, pediatric and neonatal patients except for the following: - Arrhythmia analysis is intended to use on adult patients only and is not intended and shall not be used on pediatric and neonatal population. - ST segment analysis for adult only. - When using COMEN SpO2, the monitor is intended to be used on adult patient only. - PAWP is intended for adult and pediatric patients only. - C.O. measurement is intended for adult only. - BIS monitoring is intended for adult patients only. - RM is intended for adult and pediatric patients only. - NMT monitoring is intended for adult and pediatric patients only. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. They should only be used by persons who have received adequate training in their use. The monitors are not intended for helicopter transport, hospital ambulance, or home use.