Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Dexcon Pty Ltd · Hangzhou Realy Tech Co Ltd · Class IIb · Started February 24, 2022
Good Name: Dexcon Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- February 24, 2022
- Effective Date
- February 24, 2022
- Name
- Dexcon Pty Ltd
- Country
- China
- Address
- 4th Floor 12 Building Eastern Medicine Town Xiasha Economic & Tech Development, Hangzhou, Zhejiang, 310018
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. 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 Dexcon Pty Ltd, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on February 24, 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.