Pure Global

Pulse oximeter, battery-powered - ARTG 392511

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 392511 and sponsored by Ayonz Pty Ltd, manufactured by Hunan Accurate Bio-Medical Technology Co Ltd in China. The device registration started on July 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIa
ARTG 392511
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 392511
Good Name: Ayonz Pty Ltd - Pulse oximeter, battery-powered
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A portable device intended for non-invasive spot-checking of oxygen saturation of arterial haemoglobin (SpO2) and pulse rate of adults.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
392511
Start Date
July 20, 2022
Effective Date
July 20, 2022
Sponsor
Manufacturer
Country
China
Address
6th Floor Biyang Industrial Zone Lijiacun Road Xueshi Street of Yuelu District, Changsha, Hunan Province, 410208