Pure Global

Surgical procedure kit, dental, non-medicated, single-use - ARTG 377290

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 registered under ARTG number 377290 and 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.

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TGA ARTG Official Data
Class Is
ARTG 377290
Class Is
Surgical procedure kit, dental, non-medicated, single-use
ARTG ID: 377290
Good Name: Healthware Aus Pty Ltd - Surgical procedure kit, dental, non-medicated, single-use
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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.

Device Classification
Risk Class
Class Is
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
377290
Start Date
November 02, 2021
Effective Date
November 02, 2021
Manufacturer
Country
China
Address
Suite 303 Building 4 No.406 Kang Yi Road Kang Qiao Town Pudong New District, Shanghai, 201315