Australia TGA ARTG record

Dental delivery system, portable

Australia TGA ARTG Registered Device · PROMEDCO PTY LTD · Zhengzhou Huaer Electro-Optics Technology Co Ltd · Class I · Started November 09, 2018

Good Name: PROMEDCO PTY LTD - Dental delivery system, portable

Device classification

Risk Class: Class I
Product Type: Procedure Pack
ARTG Category: General

Registration information

Start Date: November 09, 2018
Effective Date: November 09, 2018

Sponsor

Name: PROMEDCO PTY LTD

Manufacturer

Name: Zhengzhou Huaer Electro-Optics Technology Co Ltd
Country: China
Address: No 79 Zhenghua Road, Zhengzhou City, Henan Province, 450000

Intended purpose

A mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

About this record

Access comprehensive regulatory information for Dental delivery system, portable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by PROMEDCO PTY LTD, manufactured by Zhengzhou Huaer Electro-Optics Technology Co Ltd in China. The device registration started on November 09, 2018.

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.