Australia TGA ARTG record

Oximeter, pulse

Australia TGA ARTG Registered Device · MAZZEO INTERNATIONAL PTY LTD · Shenzhen Hexin ZONDAN Medical Equipment Co Ltd · Class IIb · Started August 11, 2020

Good Name: MAZZEO INTERNATIONAL PTY LTD - Oximeter, pulse

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: August 11, 2020
Effective Date: August 11, 2020

Sponsor

Name: MAZZEO INTERNATIONAL PTY LTD

Manufacturer

Name: Shenzhen Hexin ZONDAN Medical Equipment Co Ltd
Country: China
Address: Floor 14 Block D Dianlian Technology Building the Crossing between South Circle, Road and South Fuli Road, Guangming District, Shenzhen, 518106

Intended purpose

A device for transcutaneous measurement of oxygen saturation (SpO2) in the blood using light detection given from a special probe. The light produced by light-emitting diodes (LEDs) illuminates arterial tissue blood, is received by a detector and measured using the principle of spectrophotometry. Pulse rate can also be calculated.

About this record

Access comprehensive regulatory information for Oximeter, pulse in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by MAZZEO INTERNATIONAL PTY LTD, manufactured by Shenzhen Hexin ZONDAN Medical Equipment Co Ltd in China. The device registration started on August 11, 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.