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Mandible-repositioning antisnoring orthosis - ARTG 404942

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 404942 and sponsored by Digital Sleep Devices Pty Ltd, manufactured by Bluestone Dental Limited in HongKong. The device registration started on February 16, 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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TGA ARTG Official Data
Class I
ARTG 404942
Class I
Mandible-repositioning antisnoring orthosis
ARTG ID: 404942
Good Name: Digital Sleep Devices Pty Ltd - Mandible-repositioning antisnoring orthosis
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Intended Purpose

This is a removable intraoral device that is intended to be used to prevent snoring and/or obstructive sleep apnoea by repositioning the lower jaw of a person.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
404942
Start Date
February 16, 2023
Effective Date
February 16, 2023
Manufacturer
Country
HongKong
Address
Unit 601 Trendy Centre 682 Castle Peak Road, Cheung Sha Wan, Kowloon