ARTG 385550Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 385550 · Plus Medical Pty Ltd · Hangzhou Testsea Biotechnology Co Ltd · Class IIb · Started March 11, 2022
Good Name: Plus Medical Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 385550
- Start Date
- March 11, 2022
- Effective Date
- September 11, 2024
- Country
- China
- Address
- No 13-2 Guanshan Road Yuhang District, Hangzhou, Zhejiang, 311115
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 385550 and sponsored by Plus Medical Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on March 11, 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.