Pure Global

Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 390609

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 390609 and sponsored by Australia Health Products Central Pty Ltd, manufactured by Ustar Biotechnologies (Hangzhou) Ltd in China. The device registration started on June 17, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 390609
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 390609
Good Name: Australia Health Products Central Pty Ltd- Severe acute respiratory syndrome-associated coronavirus IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

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

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
390609
Start Date
June 17, 2022
Effective Date
December 05, 2022
Manufacturer
Country
China
Address
Bldg 12&4 611 Dongguan Road Binjiang District, Hangzhou, Zhejiang, 310053