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Single-patient physiologic monitoring system - ARTG 415999

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 registered under ARTG number 415999 and sponsored by Medtronic Australasia Pty Ltd, manufactured by Edan Instruments Inc in China. The device registration started on August 01, 2023.

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 415999
Class IIb
Single-patient physiologic monitoring system
ARTG ID: 415999
Good Name: Medtronic Australasia Pty Ltd - Single-patient physiologic monitoring system
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Intended Purpose

A patient monitor is intended to be used for monitoring, storing, reviewing of, and to generate alarms for, multiple physiological parameters.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
415999
Start Date
August 01, 2023
Effective Date
August 01, 2023
Manufacturer
Country
China
Address
#15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122