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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 Fortun8 International Trading Co Pty Limited, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on September 29, 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: Fortun8 International Trading Co Pty Limited - 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 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
Start Date
September 29, 2022
Effective Date
December 05, 2022
Manufacturer
Country
China
Address
No 1 Yichuang Road Yuhang Sub district, Yuhang District, Hangzhou, 311121