Australia TGA ARTG record

Multiple-viruses IVDs

Australia TGA ARTG Registered Device · Sonictec Pty Ltd · Hangzhou Realy Tech Co Ltd · Class IIb · Started April 26, 2023

Good Name: Sonictec Pty Ltd - Multiple-viruses IVDs

Device classification

Risk Class: Class IIb
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: April 26, 2023
Effective Date: July 04, 2024

Sponsor

Name: Sonictec Pty Ltd

Manufacturer

Name: Hangzhou Realy Tech Co Ltd
Country: China
Address: #2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200

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).

About this record

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 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.