Australia TGA ARTG record

Instrument/analyser IVDs

Australia TGA ARTG Registered Device · Equinox Medical Pty Ltd · 3D Biomedicine Science & Technology Co Ltd · Class I · Started November 18, 2022

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 18, 2022
Effective Date: November 18, 2022

Sponsor

Name: Equinox Medical Pty Ltd

Manufacturer

Name: 3D Biomedicine Science & Technology Co Ltd
Country: China
Address: Room 304 404 402 401 Building 2 No 158 Xinjunhuan St, Minhang District, Shanghai, 201114

Intended purpose

The ANDiS Automated Nucleic Acid Extraction System is used for nucleic acid extraction and purification in clinical samples.

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 3D Biomedicine Science & Technology Co Ltd in China. The device registration started on November 18, 2022.

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.