Australia TGA ARTG record

Single-patient physiologic monitoring system

Australia TGA ARTG Registered Device · Wiselink Group Pty Ltd · Shenzhen Comen Medical Instruments Co Ltd · Class IIb · Started April 24, 2024

Good Name: Wiselink Group Pty Ltd - Single-patient physiologic monitoring system

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: April 24, 2024
Effective Date: April 24, 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

The monitor is intended for measuring patient physiological parameters such as noninvasive blood pressure (NIBP), pulse oxygen saturation(SpO2), body temperature(Temp), pulse rate(PR). The monitor message can be displayed, reviewed and stored except being printed. It can be used in medical ward, surgical ward, clinic and emergency triage department. The expected operator position is about one meter around the monitor in normal use. The NC5/NC5A Vital Signs Monitor is designed for monitoring ECG（only for NC5）, non-invasive blood pressure (NIBP), pulse oxygen saturation (SpO2), and pulse rate (PR) of patients, as well as body temperature (TEMP) of adults, pediatrics and neonates. Monitoring information can be displayed, reviewed, stored and printed. The device is mainly used in places such as internal medicine and surgical wards, outpatient and emergency triage.

About this record

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 24, 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.