Australia TGA ARTG recordProbe, pulse oximeter, reusable
Australia TGA ARTG Registered Device · Australia Medical Alliance Services Pty Ltd T/As AMA Medical Products · Edan Instruments Inc · Class IIa · Started March 17, 2020
Good Name: AMA Services WA Pty Ltd T/A AMA Medical Products - Probe, pulse oximeter, reusable
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- Start Date
- March 17, 2020
- Effective Date
- March 17, 2020
- Country
- China
- Address
- #15 Jinhui Road Jinsha Community Kengzi Sub-District Pingshan District, Shenzhen, 518122
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
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.