Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Pharma Soul Holdings Pty Ltd · Hangzhou Testsea Biotechnology Co Ltd · Class IIb · Started August 19, 2021
Good Name: Pharma Soul Holdings Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- August 19, 2021
- Effective Date
- December 02, 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 from symptomatic individuals at the point of care by trained health professionals (nasopharyngeal and nasal swab samples) and for self-testing by lay persons (nasal samples).
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 Pharma Soul Holdings Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on August 19, 2021.
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.