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Mandible-repositioning antisnoring orthosis - ARTG 482027

Access comprehensive regulatory information for Mandible-repositioning antisnoring orthosis in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 482027 and sponsored by Share Info Pty Ltd, manufactured by Shenzhen Sany Pioneer Technology Co Ltd in China. The device registration started on March 07, 2025.

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 482027
Class I
Mandible-repositioning antisnoring orthosis
ARTG ID: 482027
Good Name: Share Info Pty Ltd - Mandible-repositioning antisnoring orthosis
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Intended Purpose

The Mandibular Advancement Device is designed to advance the user 's lower jaw and maintain this position during use, opening the airway to reduce or eliminate snoring during sleep. It is intended for adults with at least 18 years old.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
482027
Start Date
March 07, 2025
Effective Date
March 07, 2025
Manufacturer
Country
China
Address
503A 302 No 2 Factory Building Fukang Road Pinghu Community Pinghu Street, Longgang District, Shenzhen, Guangdong, 518000