Pure Global

Mixer, dental, amalgam

Access comprehensive regulatory information for Mixer, dental, amalgam in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Purus Health and Medical Technologies Pty Ltd, manufactured by Ninabo Fomos Medical Instrument Co Ltd in China. The device registration started on July 03, 2020.

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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Class I
Class I
Mixer, dental, amalgam
Australia TGA ARTG Registered Device
Good Name: Purus Health and Medical Technologies Pty Ltd - Mixer, dental, amalgam
Pure Global
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Intended Purpose

This is a bench top dental amalgamator that is intended to mix by shaking, mainly, amalgam capsules containing mercury and dental alloy particles.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
July 03, 2020
Effective Date
July 03, 2020
Sponsor
Manufacturer
Country
China
Address
No 18 Huilin Road Luotuo Street Zhenhai District, Ningbo, 315202