Australia TGA ARTG record

Nasopharyngeal swab

Australia TGA ARTG Registered Device · Southern Cross Diagnostics Pty Ltd · Shenzhen Mandelab Co Ltd · Class Is · Started June 20, 2022

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: June 20, 2022
Effective Date: June 20, 2022

Sponsor

Name: Southern Cross Diagnostics Pty Ltd

Manufacturer

Name: Shenzhen Mandelab Co Ltd
Country: China
Address: 7F & 6F Buiding #5 10th Industrial Zone Tianliao Community Yutang Street, Guangming District, Shenzhen, Guangdong, 518000

Intended purpose

Disposable Sampling Swabs intended for taking biological samples from the natural cavity of the human body for examination, such as the nasal cavity, oral cavity, throat and cervix.

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 Shenzhen Mandelab Co Ltd in China. The device registration started on June 20, 2022.

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.