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Pulse oximeter, battery-powered

Access comprehensive regulatory information for Pulse oximeter, battery-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by IFI Australia Pty Ltd, manufactured by Shanghai Berry Electronic Tech Co Ltd in China. The device registration started on September 22, 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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TGA ARTG Official Data
Class IIb
Class IIb
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: IFI Australia Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

The pulse oximeter is a reusable device and intended use for spot checking of the pulse oxygen saturation and pulse rate for adult in clinic environment to check the user for hypoxemia. This device is not for continuously monitoring.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 22, 2023
Effective Date
September 22, 2023
Manufacturer
Country
China
Address
Unit 104 1st Floor 7th Building No 1188 Lianhang Road, Minhang District, Shanghai, 201112