Australia flagARTG 430031

Multiple-viruses IVDs

ARTG ID: 430031 · Emergence Technology Pty Ltd · Assure Tech (Hangzhou) Co Ltd · Class IIb · Started December 06, 2023

Good Name: Emergence Technology Pty Ltd - Multiple-viruses IVDs

Device classification
Risk Class
Class IIb
Product Type
IVD
ARTG Category
IVD
Registration information
ARTG ID
430031
Start Date
December 06, 2023
Effective Date
September 11, 2024
Sponsor
Manufacturer
Country
China
Address
Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011
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).

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 registered under ARTG number 430031 and 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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