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Mandible-repositioning antisnoring orthosis

Australia TGA ARTG Registered Device · Digital Sleep Devices Pty Ltd · Bluestone Dental Limited · Class I · Started February 16, 2023

Good Name: Digital Sleep Devices Pty Ltd - Mandible-repositioning antisnoring orthosis

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

About this record

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 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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