Australia TGA ARTG recordSevere acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device · ProcureNet APAC Pty Ltd · Hangzhou Sejoy Electronics & Instruments Co Ltd · Class IIb · Started January 24, 2023
Good Name: ProcureNet APAC Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- Start Date
- January 24, 2023
- Effective Date
- January 25, 2023
- Country
- China
- Address
- Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100
The Medriva COVID-19 Rapid Antigen Self-test is a single-use test kit which uses a self-collected nasal swab specimen and is intended to detect SARS-CoV-2 that causes COVID-19. SARS-CoV-2 antigen testing is typically used in the acute phase of infection, with samples tested within the first 7 days of symptom onset when the antigen is generally detectable in the upper respiratory tract. The Medriva Self-test is intended to be used by lay users as a self-test in the home and workplace (in offices, airports, schools, for sporting events, etc.).
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 ProcureNet APAC Pty Ltd, manufactured by Hangzhou Sejoy Electronics & Instruments Co Ltd in China. The device registration started on January 24, 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.