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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 Emergence Technology Pty Ltd, manufactured by Assure Tech (Hangzhou) Co Ltd in China. The device registration started on December 06, 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
Class IIb
Multiple-viruses IVDs
Australia TGA ARTG Registered Device
Good Name: Emergence Technology Pty Ltd - Multiple-viruses IVDs
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Intended Purpose

Intended to detect Respiratory syncytial virus, Influenza A/B and the novel coronavirus SARS-CoV-2 as an aid in diagnosis from symptomatic individuals at the point of care by trained health professionals and for self-testing (nasal swab).

Device Classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
December 06, 2023
Effective Date
July 22, 2024
Manufacturer
Country
China
Address
Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011