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Nasal breathing aid, external - ARTG 473026

Access comprehensive regulatory information for Nasal breathing aid, external in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 473026 and sponsored by The Trustee for Vinkmann & Saarnak Family Trust, manufactured by Zhejiang Hongyu Medical Commodity Co Ltd in China. The device registration started on December 13, 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 473026
Class I
Nasal breathing aid, external
ARTG ID: 473026
Good Name: The Trustee for Vinkmann & Saarnak Family Trust - Nasal breathing aid, external
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Intended Purpose

Manufacturer's Intended Purpose of the Device: The nasal strip is a single-use, external adhesive device designed to mechanically open the nasal passages to improve airflow through the nostrils. It is intended to alleviate nasal congestion caused by colds, allergies, or deviated septums, as well as to reduce snoring associated with restricted nasal breathing during sleep. The device is applied externally to the bridge of the nose. Once adhered, its flexible bands gently lift and support the nasal passages, increasing the space within the nasal airway and improving airflow without the use of medication or invasive techniques. The nasal strip is suitable for use by individuals experiencing nasal obstruction or difficulty breathing through the nose and is recommended for both daytime and nighttime use. It may also be used to enhance breathing during physical activity or exercise. The product is non-invasive, hypoallergenic, and intended for over-the-counter consumer use. It is designed for single-use only and must be discarded after removal.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
473026
Start Date
December 13, 2024
Effective Date
December 13, 2024
Manufacturer
Country
China
Address
No 668 ChanHua Road Yi'nan Industrial District, Yiwu City, Zhejiang Province, 322002