Australia TGA ARTG record

Surgical procedure kit, dental, non-medicated, single-use

Australia TGA ARTG Registered Device · Healthware Aus Pty Ltd · Shanghai Zogear Industries Co Ltd · Class Is · Started November 02, 2021

Good Name: Healthware Aus Pty Ltd - Surgical procedure kit, dental, non-medicated, single-use

Device classification

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

Registration information

Start Date: November 02, 2021
Effective Date: November 02, 2021

Sponsor

Name: Healthware Aus Pty Ltd

Manufacturer

Name: Shanghai Zogear Industries Co Ltd
Country: China
Address: Suite 303 Building 4 No.406 Kang Yi Road Kang Qiao Town Pudong New District, Shanghai, 201315

Intended purpose

A collection of class I, hand held, non-active dental instruments, dressings and materials necessary for dental examination, diagnostic and surgical procedures which are presented in a sterile pack and which are intended for use by dental professionals only once and then disposed of after transient use in a patient's oral cavity. The packs are available in a selection of double or single ended, hand held dental instruments and may include, as required, a selection of disposable dressings and other necessary materials. The pack is for single use.

About this record

Access comprehensive regulatory information for Surgical procedure kit, dental, non-medicated, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is sponsored by Healthware Aus Pty Ltd, manufactured by Shanghai Zogear Industries Co Ltd in China. The device registration started on November 02, 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.