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Nasal irrigation saline solution, non-sterile - ARTG 346793

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 IIa is registered under ARTG number 346793 and sponsored by Haleon Australia Pty Ltd, manufactured by GSK Consumer Healthcare SARL in Switzerland. The device registration started on October 29, 2020.

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 IIa
ARTG 346793
Class IIa
Nasal irrigation saline solution, non-sterile
ARTG ID: 346793
Good Name: Haleon Australia Pty Ltd - Nasal irrigation saline solution, non-sterile
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Intended Purpose

Otrivin Breathe Clean (also known as Otrivin Sea Water with Aloe Vera) is a pressurized nasal spray that contains an isotonic natural sea water solution with Aloe Vera extract. Otrivin Breathe Clean is recommended to: โ€ข 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; โ€ข Soothe the irritated nasal passages; โ€ข Moisturise 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); โ€ข Thin and loosen nasal secretions and help their removal. Otrivin Breathe Clean is also suitable for daily nasal cleansing.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
346793
Start Date
October 29, 2020
Effective Date
October 29, 2020
Manufacturer
Country
Switzerland
Address
Route de l'Etraz, Prangins, 1197