Pure Global

Dental delivery system, portable

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.

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TGA ARTG Official Data
Class I
Class I
Dental delivery system, portable
Australia TGA ARTG Registered Device
Good Name: PROMEDCO PTY LTD - Dental delivery system, portable
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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.

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
Manufacturer
Country
China
Address
No 79 Zhenghua Road, Zhengzhou City, Henan Province, 450000