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Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 462948

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 registered under ARTG number 462948 and sponsored by 2San Pty Ltd, manufactured by Assure Tech (Hangzhou) Co Ltd in China. The device registration started on September 26, 2024.

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
ARTG 462948
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 462948
Good Name: 2San Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
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DJ Fang

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Intended Purpose

Intended to detect 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
ARTG ID
462948
Start Date
September 26, 2024
Effective Date
September 26, 2024
Sponsor
Manufacturer
Country
China
Address
Building 4 No 1418-50 Moganshan Road Gongshu District, Hangzhou, Zhejiang, 310011