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Physiologic monitor-installed software

Access comprehensive regulatory information for Physiologic monitor-installed software in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by GE Healthcare Australia Pty Ltd, manufactured by GE Healthcare Finland Oy in Finland. The device registration started on April 17, 2024.

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
Class IIb
Physiologic monitor-installed software
Australia TGA ARTG Registered Device
Good Name: GE Healthcare Australia Pty Ltd - Physiologic monitor-installed software
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Intended Purpose

The Portrait Mobile Patient Monitor Software (Portrait HSWXB) is intended to run on Portrait Mobile Patient Monitor Hardware for the continuous monitoring of oxygen saturation (SpO2), pulse rate (PR) and respiration rate (RR) parameters.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
April 17, 2024
Effective Date
April 17, 2024
Manufacturer
Country
Finland
Address
Kuortaneenkatu 2, Helsinki, FI-00510