Australia TGA ARTG record

Clinical chemistry toxicology/drug detection IVDs

Australia TGA ARTG Registered Device · APAC Security Pty Ltd · Hangzhou Clongene Biotech Co Ltd · Class IIa · Started April 14, 2016

Good Name: APAC Security Pty Ltd - Clinical chemistry toxicology/drug detection IVDs

Device classification

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

Registration information

Start Date: April 14, 2016
Effective Date: April 14, 2016

Sponsor

Name: APAC Security Pty Ltd

Manufacturer

Name: Hangzhou Clongene Biotech Co Ltd
Country: China
Address: Buiding 4 No 20 Longquan Road Cangqian Town, Yuhang District, Hangzhou, 311121

Intended purpose

On Site Drug of abuse screening device

About this record

Access comprehensive regulatory information for Clinical chemistry toxicology/drug detection IVDs in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by APAC Security Pty Ltd, manufactured by Hangzhou Clongene Biotech Co Ltd in China. The device registration started on April 14, 2016.

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.