Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · Edwards Group Pty Ltd · Edwards Group Pty Ltd · Class I · Started October 29, 2020

Good Name: Edwards Group Pty Ltd - Specimen receptacle IVDs

Device classification

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

Registration information

Start Date: October 29, 2020
Effective Date: October 29, 2020

Sponsor

Name: Edwards Group Pty Ltd

Manufacturer

Name: Edwards Group Pty Ltd
Country: Australia
Address: 41 Borthwick Avenue, Murrarie, QLD, 4172

Intended purpose

Microbial nucleic acid storage and stabilization device that consists of a container and reagents intended to stabilize microbial nucleic acids from human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.

About this record

Access comprehensive regulatory information for Specimen receptacle IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Edwards Group Pty Ltd, manufactured by Edwards Group Pty Ltd in Australia. The device registration started on October 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.