Australia TGA ARTG record

Nasopharyngeal swab

Australia TGA ARTG Registered Device · Southern Cross Diagnostics Pty Ltd · Jiangsu HanHeng Medical Technology Co Ltd · Class Is · Started March 24, 2020

Good Name: Southern Cross Diagnostics Pty Ltd - Nasopharyngeal swab

Device classification

Risk Class: Class Is
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: March 24, 2020
Effective Date: March 24, 2020

Sponsor

Name: Southern Cross Diagnostics Pty Ltd

Manufacturer

Name: Jiangsu HanHeng Medical Technology Co Ltd
Country: China
Address: 16-B4 #1 North Qingyang Road Tianning District, Changzhou, Jiangsu, 213017

Intended purpose

For the collection of specimens from a patient to be transported to a laboratory for the purpose of in vitro diagnostic examination. Only used in body orifices.

About this record

Access comprehensive regulatory information for Nasopharyngeal swab in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Southern Cross Diagnostics Pty Ltd, manufactured by Jiangsu HanHeng Medical Technology Co Ltd in China. The device registration started on March 24, 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.