Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Equinox Medical Pty Ltd · Guangzhou Four E's Healthcare Co Ltd · Class I · Started November 07, 2023

Good Name: Equinox Medical Pty Ltd - Instrument/analyser IVDs

Device classification

Risk Class: Class I
Product Type: IVD
ARTG Category: IVD

Registration information

Start Date: November 07, 2023
Effective Date: November 07, 2023

Sponsor

Name: Equinox Medical Pty Ltd

Manufacturer

Name: Guangzhou Four E's Healthcare Co Ltd
Country: China
Address: Room 405 Building C No 2 Ruitai Road Huangpu District, Guangzhou, Guangdong

Intended purpose

Automated instrument for extracting and purifying nucleic acids from human specimens for in vitro diagnostic examinations

About this record

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 November 07, 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.