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Comen CM1200 Electrocardiograph - Patient monitor, electrocardiograph

Australia TGA ARTG Registered Device · Macquarie Medical Systems Pty Ltd · Shenzhen Comen Medical Instruments Co Ltd · Class IIb · Started September 20, 2020

Good Name: Macquarie Medical Systems Pty Ltd - Comen CM1200 Electrocardiograph - Patient monitor, electrocardiograph

Device classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration information
Start Date
September 20, 2020
Effective Date
September 20, 2020
Sponsor
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
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.

About this record

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 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.

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