Australia TGA ARTG record

Multiple-viruses IVDs

Australia TGA ARTG Registered Device · APAC Security Pty Ltd · Hangzhou Clongene Biotech Co Ltd · Class IIb · Started February 14, 2023

Good Name: APAC Security Pty Ltd - Multiple-viruses IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: February 14, 2023
Effective Date: February 15, 2023

Sponsor

Name: APAC Security Pty Ltd

Manufacturer

Name: Hangzhou Clongene Biotech Co Ltd
Country: China
Address: No 1 Yichuang Road Yuhang Sub district, Yuhang District, Hangzhou, 311121

Intended purpose

Intended to detect Influenza A/B and the novel coronavirus SARS-CoV-2 from symptomatic individuals for self-testing by lay persons (nasal swab).

About this record

Access comprehensive regulatory information for Multiple-viruses IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by APAC Security Pty Ltd, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on February 14, 2023.

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.