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Edan Patient Monitor - Telemetry system, physiological signal - ARTG 326013

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 registered under ARTG number 326013 and 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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Class IIb
ARTG 326013
Class IIb
Edan Patient Monitor - Telemetry system, physiological signal
ARTG ID: 326013
Good Name: Macquarie Medical Systems Pty Ltd - Edan Patient Monitor - Telemetry system, physiological signal
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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.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
326013
Start Date
November 07, 2019
Effective Date
November 07, 2019
Manufacturer
Country
China
Address
#15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122