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Pulse oximeter, battery-powered - ARTG 348992

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 348992 and 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.

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TGA ARTG Official Data
Class IIa
ARTG 348992
Class IIa
Pulse oximeter, battery-powered
ARTG ID: 348992
Good Name: AMA Services WA Pty Ltd T/A AMA Medical Products - Pulse oximeter, battery-powered
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Intended Purpose

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

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
348992
Start Date
November 19, 2020
Effective Date
November 19, 2020
Manufacturer
Country
China
Address
RM6H02 Block 27-29 Tianxia IC Industrial Park Majialong No 133 of Yiyuan Road, Nantou Street, Nanshan District Shenzhen, 518052