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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 Dexcon Pty Ltd, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on February 24, 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.

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

Intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. For self-testing by lay persons (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 24, 2022
Effective Date
February 24, 2022
Sponsor
Manufacturer
Country
China
Address
4th Floor 12 Building Eastern Medicine Town Xiasha Economic & Tech Development, Hangzhou, Zhejiang, 310018