Australia TGA ARTG record

Specimen receptacle IVDs

Australia TGA ARTG Registered Device · Edwards Group Pty Ltd · Citotest Labware Manufacturing Co Ltd · Class I · Started April 03, 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: April 03, 2020
Effective Date: April 03, 2020

Sponsor

Name: Edwards Group Pty Ltd

Manufacturer

Name: Citotest Labware Manufacturing Co Ltd
Country: China
Address: No 48 Xinxiu Road, Haimen City, Jiangsu, 226100

Intended purpose

Intended to take and transport clinical specimens for testing against bacteria/viruses. Consists of a swab and container.

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 Citotest Labware Manufacturing Co Ltd in China. The device registration started on April 03, 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.