Australia TGA ARTG record

Single-patient physiologic monitoring system

Australia TGA ARTG Registered Device · Zone Medical Pty Ltd · Northern Meditec Limited · Class IIb · Started May 19, 2016

Good Name: Zone Medical 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: May 19, 2016
Effective Date: May 19, 2016

Sponsor

Name: Zone Medical Pty Ltd

Manufacturer

Name: Northern Meditec Limited
Country: China
Address: Room 420 422 425 426 428 - Forth Floor Block B1, Famous Industrial Products Exhibition & Purchasing Centre - No 168 Baoyuan Road, Xixiang - Boa an Dist, Shenzhen, 518102

Intended purpose

This monitor is intended to be used for monitoring, trends, storing, reviewing, recording, and generating alarms for multiple physiological parameters which may include ECG, respiration (RESP), temperature (TEMP), oxygen saturation of arterial blood (SpO2), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), Cardiac Output (C.O.) and Anesthetic gas (AG) of adults, pediatrics and neonates in hospital environments. This monitor is configurable to be suitable for use in hospital environments which may include intra-hospital transport and hospital environments including clinic, emergency department, wards, PACU and NICU.OR, ICU, NICU, PACU and wards.

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 Zone Medical Pty Ltd, manufactured by Northern Meditec Limited in China. The device registration started on May 19, 2016.

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.