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Pulse oximeter, battery-powered

Australia TGA ARTG Registered Device · Ergo Health Group Pty Ltd · Shenzhen Aeon Technology Co Ltd · Class IIa · Started June 14, 2023

Good Name: Ergo Health Group Pty Ltd - Pulse oximeter, battery-powered

Device classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration information
Start Date
June 14, 2023
Effective Date
June 14, 2023
Sponsor
Manufacturer
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

A device used for non-invasive measurement of oxygen saturation and 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 Ergo Health Group Pty Ltd, manufactured by Shenzhen Aeon Technology Co Ltd in China. The device registration started on June 14, 2023.

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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