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Inhalation-therapy sterile saline solution, hypertonic - ARTG 275201

Access comprehensive regulatory information for Inhalation-therapy sterile saline solution, hypertonic in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class Is is registered under ARTG number 275201 and sponsored by The Royal Children's Hospital, manufactured by Briemar Nominees Pty Ltd in Australia. The device registration started on May 10, 2016.

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 Is
ARTG 275201
Class Is
Inhalation-therapy sterile saline solution, hypertonic
ARTG ID: 275201
Good Name: The Royal Children's Hospital - Inhalation-therapy sterile saline solution, hypertonic
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Intended Purpose

Hypertonic saline (a concentrated sterile saline solution) designed for inhalation via a nebuliser. May assist in the thinning of viscous respiratory mucous secretions. Intended for the induction of sputum in the lower respiratory tract, via physiological osmotic mechanisms, in patients with persistent mucus accumulation associated with suppurative lung conditions (eg. cystic fibrosis, bronchiectasis). The osmotic mechanism is a physical not pharmacological process. Once used, the saline solution cannot be reused.

Device Classification
Risk Class
Class Is
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
275201
Start Date
May 10, 2016
Effective Date
May 10, 2016
Manufacturer
Country
Australia
Address
100 Moody Street, KOO WEE RUP, VIC, 3981