Pure Global

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 IIa is sponsored by Ausmed Supplies Pty Ltd, manufactured by Shenzhen Hexin ZONDAN Medical Equipment Co Ltd in China. The device registration started on September 28, 2021.

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
Class IIa
Pulse oximeter, battery-powered
Australia TGA ARTG Registered Device
Good Name: Ausmed Supplies Pty Ltd - Pulse oximeter, battery-powered
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Intended Purpose

A handheld, finger pulse oximeter, a non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients./

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
September 28, 2021
Effective Date
September 28, 2021
Sponsor
Manufacturer
Country
China
Address
Floor 14 Block D Dianlian Technology Building the Crossing between South Circle, Road and South Fuli Road, Guangming District, Shenzhen, 518106