Pure Global

Comen CM1200 Electrocardiograph - Patient monitor, electrocardiograph - ARTG 343770

Access comprehensive regulatory information for Comen CM1200 Electrocardiograph - Patient monitor, electrocardiograph in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 343770 and sponsored by Macquarie Medical Systems Pty Ltd, manufactured by Shenzhen Comen Medical Instruments Co Ltd in China. The device registration started on September 20, 2020.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 343770
Class IIb
Comen CM1200 Electrocardiograph - Patient monitor, electrocardiograph
ARTG ID: 343770
Good Name: Macquarie Medical Systems Pty Ltd - Comen CM1200 Electrocardiograph - Patient monitor, electrocardiograph
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A device that processes and displays the patient's electrocardiogram (ECG), electrical activity of the heart. Some ECG monitors also display the heart frequency. It may produce visible and/or audible signals/alarms when adverse conditions are registered.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
343770
Start Date
September 20, 2020
Effective Date
September 20, 2020
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