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Multiple-viruses IVDs - ARTG 402449

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 registered under ARTG number 402449 and 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
ARTG 402449
Class IIb
Multiple-viruses IVDs
ARTG ID: 402449
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
ARTG ID
402449
Start Date
January 18, 2023
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
#2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200