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Pap Smear Combination Kit - Papanicolaou smear kit - ARTG 367450

Access comprehensive regulatory information for Pap Smear Combination Kit - Papanicolaou smear kit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 367450 and 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.

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TGA ARTG Official Data
Class Is
ARTG 367450
Class Is
Pap Smear Combination Kit - Papanicolaou smear kit
ARTG ID: 367450
Good Name: Thermo Fisher Scientific Australia Pty Ltd - Pap Smear Combination Kit - Papanicolaou smear kit
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Intended Purpose

A kit containing a cervical brush and broom required to obtain a cytology sample from the cervix and perform a papanicolaou (PAP) test.

Device Classification
Risk Class
Class Is
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
367450
Start Date
May 27, 2021
Effective Date
May 27, 2021
Manufacturer
Country
China
Address
#118 Xinyuan 3rd Road Xinbei District, Changzhou, Jiangsu, 213031