Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · ProcureNet APAC Pty Ltd · Hangzhou Testsea Biotechnology Co Ltd · Class IIb · Started February 10, 2022
Good Name: ProcureNet APAC Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- February 10, 2022
- Effective Date
- December 05, 2022
- Country
- China
- Address
- 3rd Floor Building 6 North No 8-2 Keji Avenue Yuhang District, Hangzhou, Zhejiang Province, 311121
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19, for self-testing by lay persons (anterior nasal swabs).
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 ProcureNet APAC Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on February 10, 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.