Australia TGA ARTG record

Inhalation-therapy sterile saline solution, hypertonic

Australia TGA ARTG Registered Device · The Royal Children's Hospital · Briemar Nominees Pty Ltd · Class Is · Started May 10, 2016

Good Name: The Royal Children's Hospital - Inhalation-therapy sterile saline solution, hypertonic

Device classification

Risk Class: Class Is
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: May 10, 2016
Effective Date: May 10, 2016

Sponsor

Name: The Royal Children's Hospital

Manufacturer

Name: Briemar Nominees Pty Ltd
Country: Australia
Address: 100 Moody Street, KOO WEE RUP, VIC, 3981

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.

About this record

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 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.