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Specimen receptacle IVDs - ARTG 346757

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 registered under ARTG number 346757 and 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.

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Class I
ARTG 346757
Class I
Specimen receptacle IVDs
ARTG ID: 346757
Good Name: Edwards Group Pty Ltd - Specimen receptacle IVDs
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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.

Device Classification
Risk Class
Class I
Product Type
IVD
ARTG Category
IVD
Registration Information
ARTG ID
346757
Start Date
October 29, 2020
Effective Date
October 29, 2020
Manufacturer
Country
Australia
Address
41 Borthwick Avenue, Murrarie, QLD, 4172