Australia TGA ARTG record

Multi-parameter Patient Monitor - Single-patient physiologic monitoring system

Australia TGA ARTG Registered Device · Wiselink Group Pty Ltd · Shenzhen Comen Medical Instruments Co Ltd · Class IIb · Started May 23, 2024

Good Name: Wiselink Group Pty Ltd - Multi-parameter Patient Monitor - Single-patient physiologic monitoring system

Device classification

Risk Class: Class IIb
Product Type: Medical device system
ARTG Category: General

Registration information

Start Date: May 23, 2024
Effective Date: May 23, 2024

Sponsor

Name: Wiselink Group Pty Ltd

Manufacturer

Name: Shenzhen Comen Medical Instruments Co Ltd
Country: China
Address: Floor 10 Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5, of Building 2 FIYTA Timepiece Building Nanhuan Avenue Matian Sub-district, Guangming District Shenzhen, Guangdong, 518106

Intended purpose

KPro series patient monitor is a multi-parameter physiological patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The monitors support multiple non-invasive and invasive measurements, including ECG (3-lead, 5-lead, 6-lead or 12-lead selectable), Arrhythmia Analysis, ST Segment Analysis, QT Analysis, interpretation of resting 12-lead ECG, Heart Rate (HR), Respiration rate (impedance respiration and CO2 airway gas), Temperature (Temp), Pulse Rate (PR), Pulse Oxygen Saturation (SpO2), Masimo Rainbow SpO2, Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP) , Pulmonary Artery Wedge Pressure (PAWP), Cardiac Output (C.O.), Impedance Cardiograph (ICG), Bispectral Index (BIS), SedLine EEG, Respiration Mechanics (RM), Neuromuscular Transmission Monitoring (NMT), Regional Oxygen Saturation (rSO2), Carbon Dioxide (CO2), Anesthesia gas (AG) and Oxygen (O2) respiratory gas monitoring. The monitors are to be used in healthcare facilities by clinical professionals or under their guidance. The monitors are not intended for helicopter transport, hospital ambulance or home use. All the parameters can be monitored on single adult, pediatric and neonatal patients except for the following: - Arrhythmia analysis and PAWP is intended for adult and pediatric patients only. - C.O. measurement is intended for adult only. - PAWP measurement is not applied for neonatal. - NMT monitoring is intended for adult and pediatric patients only. - ICG monitoring is indicated for patients older than 13 years, with height range of 120 - 230cm, weight range: 30 - 155 kg. - BIS monitoring is intended for adult and pediatric patients only. - Masimo Sedline EEG monitoring is intended for adult and pediatric patients (beyond 18 years) only - Masimo O3 monitoring is indicated for adult patients >40 kg and on pediatrics > 5 kg and < 40 kg in healthcare environments.

About this record

Access comprehensive regulatory information for Multi-parameter Patient Monitor - 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 May 23, 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.