Australia TGA ARTG record

Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Australia Medical Alliance Services Pty Ltd T/As AMA Medical Products · Shenzhen Aeon Technology Co Ltd · Class IIa · Started November 19, 2020

Good Name: AMA Services WA Pty Ltd T/A AMA Medical Products - Pulse oximeter, battery-powered

Device classification

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

Registration information

Start Date: November 19, 2020
Effective Date: November 19, 2020

Sponsor

Name: Australia Medical Alliance Services Pty Ltd T/As AMA Medical Products

Manufacturer

Name: Shenzhen Aeon Technology Co Ltd
Country: China
Address: RM6H02 Block 27-29 Tianxia IC Industrial Park Majialong No 133 of Yiyuan Road, Nantou Street, Nanshan District Shenzhen, 518052

Intended purpose

The Fingertip Pulse Oximeter, for the non invasive measurement of SpO2 oxygen saturation and blood pulse rate.

About this record

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 Australia Medical Alliance Services Pty Ltd T/As AMA Medical Products, manufactured by Shenzhen Aeon Technology Co Ltd in China. The device registration started on November 19, 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.