Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Big Start Pty Ltd · Guangzhou Decheng Biotechnology Co Ltd · Class IIb · Started April 12, 2022
Good Name: Big Start Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- April 12, 2022
- Effective Date
- December 05, 2022
- Country
- China
- Address
- Room 405 Room 218 Room 212 and Room 107 Building 2 No 68 Nanxiang 1st Road, Science City, Huangpu District Guangzhou, Guangdong, 510663
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 Big Start Pty Ltd, manufactured by Guangzhou Decheng Biotechnology Co Ltd in China. The device registration started on April 12, 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.