Pure Global

Severe acute respiratory syndrome-associated coronavirus IVDs - ARTG 409956

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 409956 and sponsored by Wellwisse Pharmaceuticals Pty Ltd, manufactured by Hangzhou Testsea Biotechnology Co Ltd in China. The device registration started on June 02, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class IIb
ARTG 409956
Class IIb
Severe acute respiratory syndrome-associated coronavirus IVDs
ARTG ID: 409956
Good Name: Wellwisse Pharmaceuticals Pty Ltd - Severe acute respiratory syndrome-associated coronavirus IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

Intended to detect Influenza A/B and 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
409956
Start Date
June 02, 2023
Effective Date
September 11, 2024
Manufacturer
Country
China
Address
3rd Floor Building 6 North No 8-2 Keji Avenue Yuhang District, Hangzhou, Zhejiang Province, 311121