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Nasal irrigation saline solution, non-sterile

Access comprehensive regulatory information for Nasal irrigation saline solution, non-sterile in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Haleon Australia Pty Ltd, manufactured by GSK Consumer Healthcare SARL in Switzerland. The device registration started on February 02, 2021.

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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Class I
Class I
Nasal irrigation saline solution, non-sterile
Australia TGA ARTG Registered Device
Good Name: Haleon Australia Pty Ltd - Nasal irrigation saline solution, non-sterile
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Intended Purpose

Nasal Spray with an isotonic saline solution which salt concentration is optimised to prevent nasal irritation. The solution contains castor oil, which is known to have moisturizing and emollient properties. It is recommended to: - Gently cleanse the nasal cavities when the nose is blocked, e.g. during a cold or in allergic conditions, by washing away the excess mucus or the allergen particles, such as dust or pollen; - Moisturize the nasal mucosa when dry or irritated in case of minor nasal irritations or due to low humidity (e.g. due to heated/air-conditioned rooms, high altitude, air travelling); - Thin and loosen nasal secretions and help their removal. Suitable for infants, children and adults. However, medical advice should be sought before using it on an infant less than 2 weeks old.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
February 02, 2021
Effective Date
February 02, 2021
Manufacturer
Country
Switzerland
Address
Route de l'Etraz, Prangins, 1197