Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Wellwisse Pharmaceuticals Pty Ltd · Hangzhou Testsea Biotechnology Co Ltd · Class IIb · Started June 02, 2023
Good Name: Wellwisse Pharmaceuticals Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- June 02, 2023
- Effective Date
- June 05, 2023
- Country
- China
- Address
- 3rd Floor Building 6 North No 8-2 Keji Avenue Yuhang District, Hangzhou, Zhejiang Province, 311121
Intended to detect Influenza A/B and the novel coronavirus SARS-CoV-2 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 Wellwisse Pharmaceuticals Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on June 02, 2023.
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.