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Orthodontic appliance cleaner, automatic - ARTG 464885

Access comprehensive regulatory information for Orthodontic appliance cleaner, automatic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 464885 and sponsored by byte Au Unit Trust, manufactured by Huizhou Gold Rose Technology Co Ltd in China. The device registration started on October 18, 2024.

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
ARTG 464885
Class I
Orthodontic appliance cleaner, automatic
ARTG ID: 464885
Good Name: byte Au Unit Trust - Orthodontic appliance cleaner, automatic
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Intended Purpose

An ultrasonic device used to clean the surface of orthodontic aligners or retainers (appliances). The orthodontic appliances are placed in a receptacle with water and can be use with appropriate cleansing tablet to cleaned via an automated cycle. This is a reusable device.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
464885
Start Date
October 18, 2024
Effective Date
October 18, 2024
Manufacturer
Country
China
Address
Left 2nd Floor No3 Lejin North Road No 24 District Zhongkai Development Zone, Huizhou, Guangdong, 516000