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Severe acute respiratory syndrome-associated coronavirus IVDs

Access comprehensive regulatory information for Severe acute respiratory syndrome-associated coronavirus 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 April 17, 2020.

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
Severe acute respiratory syndrome-associated coronavirus IVDs
Australia TGA ARTG Registered Device
Good Name: Auscan Medbio Pty Limited - Severe acute respiratory syndrome-associated coronavirus IVDs
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Intended Purpose

Rapid tests intended for use at the point-of-care to detect the presence of, or exposure to, SARS-CoV-2 in relevant specimen samples.

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
April 17, 2020
Effective Date
November 30, 2022
Manufacturer
Country
China
Address
#2 Building No 763 Yuansha Village Xinjie Street, Xiaoshan District Hangzhou City, Zhejiang, 311200