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Mandible-repositioning antisnoring orthosis - ARTG 471265

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 471265 and sponsored by Digital Sleep Devices Pty Ltd, manufactured by Good Sleep Co Pty Ltd in Singapore. The device registration started on December 02, 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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TGA ARTG Official Data
Class I
ARTG 471265
Class I
Mandible-repositioning antisnoring orthosis
ARTG ID: 471265
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 assist in and or prevent snoring and/or obstructive sleep apnoea by moving and repositioning the lower jaw (mandible) of a person, in a downward and forward position.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
471265
Start Date
December 02, 2024
Effective Date
December 02, 2024
Manufacturer
Country
Singapore
Address
105 Cecil Street #18-18 The Octagon, Singapore, 069534