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Bath, ultrasonic cleaning unit

Access comprehensive regulatory information for Bath, ultrasonic cleaning unit in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Durodent Holdings Pty Ltd, manufactured by Elma Schmidbauer GmbH in Germany. The device registration started on August 23, 2023.

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
Bath, ultrasonic cleaning unit
Australia TGA ARTG Registered Device
Good Name: Durodent Holdings Pty Ltd - Bath, ultrasonic cleaning unit
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Intended Purpose

An ultrasonic cleaning device used for pre-cleaning and cleaning dental appliances, objects, instruments and materials submerged in cleaning fluid using ultrasonic waves transmitted through a medium e.g. water. The cleaning effect is produced by the physical action of the ultrasound generated by the unit. The cleaning power can be boosted by adding suitable cleaning agents and by increasing the temperature and duration of the bath. The unit is also authorised for use in typical laboratory applications. Used with original accessories manufactured for the unit.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
August 23, 2023
Effective Date
August 23, 2023
Manufacturer
Country
Germany
Address
Gottlieb-Daimler-Str 17, Singen, D-78224