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Single-patient physiologic monitoring system - ARTG 446610

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 registered under ARTG number 446610 and 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.

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Class IIb
ARTG 446610
Class IIb
Single-patient physiologic monitoring system
ARTG ID: 446610
Good Name: Wiselink Group Pty Ltd - Single-patient physiologic monitoring system
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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๏ผˆonly for NC5๏ผ‰, 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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
446610
Start Date
April 24, 2024
Effective Date
April 24, 2024
Manufacturer
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