Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Australia Health Products Central Pty Ltd · Ustar Biotechnologies (Hangzhou) Ltd · Class IIb · Started June 17, 2022
Good Name: Australia Health Products Central Pty Ltd- Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- June 17, 2022
- Effective Date
- December 05, 2022
- Country
- China
- Address
- Bldg 12&4 611 Dongguan Road Binjiang District, Hangzhou, Zhejiang, 310053
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals for self-testing by lay persons (nasal swab).
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 Australia Health Products Central Pty Ltd, manufactured by Ustar Biotechnologies (Hangzhou) Ltd in China. The device registration started on June 17, 2022.
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.