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Multiple-viruses IVDs

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.

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Class IIb
Class IIb
Multiple-viruses IVDs
Australia TGA ARTG Registered Device
Good Name: APAC Security Pty Ltd - Multiple-viruses IVDs
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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).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
February 14, 2023
Effective Date
February 15, 2023
Manufacturer
Country
China
Address
No 1 Yichuang Road Yuhang Sub district, Yuhang District, Hangzhou, 311121