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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 Auscan Medbio Pty Limited, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on January 18, 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: Auscan Medbio Pty Limited - Multiple-viruses IVDs
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Intended Purpose

Intended to detect Influenza A/B and the novel coronavirus SARS-CoV-2 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
January 18, 2023
Effective Date
January 19, 2023
Manufacturer
Country
China
Address
#2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200