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Mandible-repositioning antisnoring orthosis

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 KD & A Pty Ltd, manufactured by OrthoApnea SL in Spain. The device registration started on December 01, 2022.

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
Class I
Mandible-repositioning antisnoring orthosis
Australia TGA ARTG Registered Device
Good Name: KD & A Pty Ltd - Mandible-repositioning antisnoring orthosis
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Intended Purpose

OrthoApnea NOA is a mandibular advance device (MAD) indicated for mild to moderate obstructive sleep apnea (OSA) and to alleviate or reduce snoring in adults.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
December 01, 2022
Effective Date
December 01, 2022
Sponsor
Manufacturer
Country
Spain
Address
C/ Flauta Magica 22, Malaga, 29006