Pure Global

Instrument/analyser IVDs

Access comprehensive regulatory information for Instrument/analyser IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Equinox Medical Pty Ltd, manufactured by Guangzhou Four E's Healthcare Co Ltd in China. The device registration started on January 16, 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Instrument/analyser IVDs
Australia TGA ARTG Registered Device
Good Name: Equinox Medical Pty Ltd - Instrument/analyser IVDs
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

The Real-Time Fluorescent Quantitative PCR System uses fluorescence real-time detection method to analyze the amplification of PCR template. It is suitable for use as an in vitro diagnostic medical device (IVD) for the purposes of processing, examining and/or providing information about a clinical specimen.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
January 16, 2024
Effective Date
January 16, 2024
Manufacturer
Country
China
Address
Room 405 Building C No 2 Ruitai Road Huangpu District, Guangzhou, Guangdong