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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 Sonictec Pty Ltd, manufactured by Hangzhou Fanttest Biotech Co Ltd in China. The device registration started on September 07, 2022.

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: Sonictec 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
September 07, 2022
Effective Date
September 07, 2022
Sponsor
Manufacturer
Country
China
Address
Room 201 Building 1 No 37-3 Futang Road Tangqi Town Linping District, Hangzhou City, Zhejiang Province