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Edan Patient Monitor - Telemetry system, physiological signal

Australia TGA ARTG Registered Device · Macquarie Medical Systems Pty Ltd · Edan Instruments Inc · Class IIb · Started November 07, 2019

Good Name: Macquarie Medical Systems Pty Ltd - Edan Patient Monitor - Telemetry system, physiological signal

Device classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration information
Start Date
November 07, 2019
Effective Date
November 07, 2019
Sponsor
Manufacturer
Country
China
Address
#15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122
Intended purpose

Telemetry devices worm by patients for short periods of time under supervision in a hospital or rehabilitation facility that measure various parameters including ECG, heart rate, and SPO2 parameters with optional links back to a central station monitoring station for clinical review.

About this record

Access comprehensive regulatory information for Edan Patient Monitor - Telemetry system, physiological signal 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 Edan Instruments Inc in China. The device registration started on November 07, 2019.

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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