Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · Australia Health Products Central Pty Ltd · Hangzhou Testsea Biotechnology Co Ltd · Class IIb · Started September 28, 2021
Good Name: Australia Health Products Central Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- September 28, 2021
- Effective Date
- March 06, 2024
- Country
- China
- Address
- No 13-2 Guanshan Road Yuhang District, Hangzhou, Zhejiang, 311115
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals for point of care testing (nasopharyngeal swab and nasal swab) and self-testing by lay persons (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 Australia Health Products Central Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on September 28, 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.