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Mandible-repositioning antisnoring orthosis - ARTG 455371

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 455371 and sponsored by The Weringa Group Pty Ltd, manufactured by Vivos Therapeutics Inc in United States of America. The device registration started on July 15, 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 455371
Class I
Mandible-repositioning antisnoring orthosis
ARTG ID: 455371
Good Name: The Weringa Group Pty Ltd - Mandible-repositioning antisnoring orthosis
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Intended Purpose

Intended to be used to reduce nighttime snoring and mild to moderate sleep apnoea in adults.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
455371
Start Date
July 15, 2024
Effective Date
July 15, 2024
Manufacturer
Country
United States of America
Address
300 S 5th Street, Murray, KY, 42071