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Probe, pulse oximeter, reusable

Access comprehensive regulatory information for Probe, pulse oximeter, reusable 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 Edan Instruments Inc in China. The device registration started on March 17, 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
Class IIa
Probe, pulse oximeter, reusable
Australia TGA ARTG Registered Device
Good Name: AMA Services WA Pty Ltd T/A AMA Medical Products - Probe, pulse oximeter, reusable
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Intended Purpose

Re-usable pulse oximeter probe used to indirectly measure the oxygen saturation of blood haemoglobin when applied to a body site, eg finger, ear or foot of a patient where it transmits light through the skin to be absorbed by the oxyhaemoglobin and deoxyhaemaglobin, in the arterial tissue blood

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 17, 2020
Effective Date
March 17, 2020
Manufacturer
Country
China
Address
#15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122