Pure Global

Instrument/analyser IVDs - ARTG 399645

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 registered under ARTG number 399645 and 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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
ARTG 399645
Class I
Instrument/analyser IVDs
ARTG ID: 399645
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 Automated Nucleic Acid Extraction System is used for nucleic acid extraction and purification in clinical samples.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
399645
Start Date
November 18, 2022
Effective Date
November 18, 2022
Manufacturer
Country
China
Address
Room 304 404 402 401 Building 2 No 158 Xinjunhuan St, Minhang District, Shanghai, 201114