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Pulse oximeter, battery-powered - ARTG 351760

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 351760 and sponsored by TV Innovations Pty Ltd, manufactured by Hunan Accurate Bio-Medical Technology Co Ltd in China. The device registration started on December 15, 2020.

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 351760
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 351760
Good Name: TV Innovations Pty Ltd - Pulse oximeter, battery-powered
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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
351760
Start Date
December 15, 2020
Effective Date
December 15, 2020
Manufacturer
Country
China
Address
6th Floor Biyang Industrial Zone Lijiacun Road Xueshi Street of Yuelu District, Changsha, Hunan Province, 410208