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Severe acute respiratory syndrome-associated coronavirus IVDs

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.

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Class IIb
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device
Good Name: ProcureNet APAC Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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Intended Purpose

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.).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
January 24, 2023
Effective Date
January 25, 2023
Manufacturer
Country
China
Address
Area C Building 2 No 365 Wuzhou Road Yuhang Economic Development Zone, Hangzhou City, Zhejiang, 311100