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Multiple-viruses IVDs - ARTG 408073

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 408073 and sponsored by Sonictec Pty Ltd, manufactured by Hangzhou Realy Tech Co Ltd in China. The device registration started on April 26, 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 408073
Class IIb
Multiple-viruses IVDs
ARTG ID: 408073
Good Name: Sonictec Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

Intended for the detection of combination SARS-CoV-2, influenza A&B or RSV antigens in human anterior nasal swab specimens from symptomatic individuals as an aid for diagnosis (Self-testing).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
408073
Start Date
April 26, 2023
Effective Date
September 11, 2024
Sponsor
Manufacturer
Country
China
Address
#2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200