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 3D Biomedicine Science & Technology Co Ltd in China. The device registration started on June 29, 2020.

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 ANDiS 350 Automated Nucleic Acid Extraction System is intended for research or in vitro diagnostic (IVD) use in performing nucleic acid testing in research or clinical laboratories. It is compatible with different magnetic bead-based nucleic acid extraction reagents and enables rapid extraction of DNA and RNA from a wide range of specimens.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
Start Date
June 29, 2020
Effective Date
June 29, 2020
Manufacturer
Country
China
Address
Block A Building 2 No 158 Xinjunhuan Road, Shanghai, 201114