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Pulse oximeter, battery-powered - ARTG 382891

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 IIa is registered under ARTG number 382891 and sponsored by A & D Australasia Pty Ltd, manufactured by Contec Medical Systems Co Ltd in China. The device registration started on January 20, 2022.

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 IIa
ARTG 382891
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 382891
Good Name: A & D Australasia Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

The Pulse Oximeter is a non-invasive device intended for the spot-check of saturation of arterial hemoglobin(SpO2) and the pulse rate of adult in home use environments. This device is not intended for continuous monitoring. The device can be used multiple times. Pulse oximeter intended for wellness use.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
382891
Start Date
January 20, 2022
Effective Date
January 20, 2022
Manufacturer
Country
China
Address
No 112 Qinhuang West Street Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004