ARTG 396675Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 396675 · Fortun8 International Trading Co Pty Limited · Hangzhou Clongene Biotech Co Ltd · Class IIb · Started September 29, 2022
Good Name: Fortun8 International Trading Co Pty Limited - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 396675
- Start Date
- September 29, 2022
- Effective Date
- September 11, 2024
- Country
- China
- Address
- No 1 Yichuang Road Yuhang Sub district, Yuhang District, Hangzhou, 311121
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 registered under ARTG number 396675 and sponsored by Fortun8 International Trading Co Pty Limited, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on September 29, 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.