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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 ACRA Regulatory Services Pty Ltd, manufactured by Contec Medical Systems Co Ltd in China. The device registration started on March 22, 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 IIb
Class IIb
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: ACRA Regulatory Services Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

Non-invasive battery operated pulse oximeter intended to be used in measuring the pulse oxygen saturation of arterial haemoglobin(SpO2) and pulse rate through finger in home use environments. This device is not intended for continuous monitoring. The device can be used multiple times.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 22, 2022
Effective Date
March 22, 2022
Manufacturer
Country
China
Address
No 112 Qinhuang West Street Economic & Technical Development Zone, Qinhuangdao, Hebei Province, 066004