Australia TGA ARTG record

Cervical cytology brush

Australia TGA ARTG Registered Device · Thermo Fisher Scientific Australia Pty Ltd · Jiangsu HanHeng Medical Technology Co Ltd · Class Is · Started May 27, 2021

Good Name: Thermo Fisher Scientific Australia Pty Ltd - Cervical cytology brush

Device classification

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

Registration information

Start Date: May 27, 2021
Effective Date: May 27, 2021

Sponsor

Name: Thermo Fisher Scientific Australia Pty Ltd

Manufacturer

Name: Jiangsu HanHeng Medical Technology Co Ltd
Country: China
Address: #118 Xinyuan 3rd Road Xinbei District, Changzhou, Jiangsu, 213031

Intended purpose

A device with bristle-like projections designed to obtain a biopsy of endo or ecto cervix during a vaginal examination for the purpose of obtaining a tissue diagnosis (Pap test) from a woman.

About this record

Access comprehensive regulatory information for Cervical cytology brush in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Thermo Fisher Scientific Australia Pty Ltd, manufactured by Jiangsu HanHeng Medical Technology Co Ltd in China. The device registration started on May 27, 2021.

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.