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oximeter - Oximeter, pulse

Access comprehensive regulatory information for oximeter - Oximeter, pulse in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by Australian Sales and Trade Services (ASTS), manufactured by Shenzhen Aeon Technology Co Ltd in China. The device registration started on June 04, 2019.

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
oximeter - Oximeter, pulse
Australia TGA ARTG Registered Device
Good Name: Australian Sales and Trade Services (ASTS) - oximeter - Oximeter, pulse
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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 and electrocardiogram (ECG) can also be calculated.

Device Classification
Risk Class
Class IIa
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
June 04, 2019
Effective Date
June 04, 2019
Manufacturer
Country
China
Address
RM6H02 Block 27-29 Tianxia IC Industrial Park Majialong No 133 of Yiyuan Road, Nantou Street, Nanshan District Shenzhen, 518052