Australia TGA ARTG recordMultiple-viruses IVDs
Australia TGA ARTG Registered Device · Emergence Technology Pty Ltd · Assure Tech (Hangzhou) Co Ltd · Class IIb · Started December 06, 2023
Good Name: Emergence Technology Pty Ltd - Multiple-viruses IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- December 06, 2023
- Effective Date
- July 22, 2024
- Country
- China
- Address
- Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011
Intended to detect Respiratory syncytial virus, Influenza A/B and the novel coronavirus SARS-CoV-2 as an aid in diagnosis from symptomatic individuals at the point of care by trained health professionals and for self-testing (nasal swab).
Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Emergence Technology Pty Ltd, manufactured by Assure Tech (Hangzhou) Co Ltd in China. The device registration started on December 06, 2023.
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.