ARTG 382615Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 382615 · Doncaster Australia Pty Ltd · Hangzhou Realy Tech Co Ltd · Class IIb · Started January 14, 2022
Good Name: Doncaster Australia Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
- Risk Class
- Class IIb
- Product Type
- IVD
- ARTG Category
- IVD
- ARTG ID
- 382615
- Start Date
- January 14, 2022
- Effective Date
- September 11, 2024
- Country
- China
- Address
- #2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200
Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 from symptomatic individuals at the point of care by trained health professionals (nasopharyngeal swab) and 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 382615 and sponsored by Doncaster Australia Pty Ltd, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on January 14, 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.