ARTG 462948Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 462948 · 2San Pty Ltd · Assure Tech (Hangzhou) Co Ltd · Class IIb · Started September 26, 2024
Good Name: 2San Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 462948
- Start Date
- September 26, 2024
- Effective Date
- September 26, 2024
- Name
- 2San Pty Ltd
- Country
- China
- Address
- Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011
Intended to detect the novel coronavirus SARS-CoV-2 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 462948 and sponsored by 2San Pty Ltd, manufactured by Assure Tech (Hangzhou) Co Ltd in China. The device registration started on September 26, 2024.
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.