Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Auscan Medbio Pty Limited · Hangzhou Realy Tech Co Ltd · Class IIb · Started April 17, 2020
Good Name: Auscan Medbio Pty Limited - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- April 17, 2020
- Effective Date
- November 30, 2022
- Country
- China
- Address
- #2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200
Rapid tests intended for use at the point-of-care to detect the presence of, or exposure to, SARS-CoV-2 in relevant specimen samples.
Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Auscan Medbio Pty Limited, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on April 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.