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Gastro-oesophageal antireflux barrier - ARTG 462415

Access comprehensive regulatory information for Gastro-oesophageal antireflux barrier in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 462415 and sponsored by Aspen Pharmacare Australia Pty Ltd, manufactured by DMG Italia Srl in Italy. The device registration started on September 19, 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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Class IIa
ARTG 462415
Class IIa
Gastro-oesophageal antireflux barrier
ARTG ID: 462415
Good Name: Aspen Pharmacare Australia Pty Ltd - Gastro-oesophageal antireflux barrier
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Intended Purpose

Oral spray intended for the temporary relief of symptoms from gastric acid reflux by the use of a protective mucoadhesive lining on the tissues of the oropharynx. This device is available [non-prescription] over-the-counter (OTC) for home use and may be used to treat gastro-oesophageal reflux disease (GERD) of various causes.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
462415
Start Date
September 19, 2024
Effective Date
September 19, 2024
Manufacturer
Country
Italy
Address
Via Laurentina Km 26, Pomezia, Rome, 700-00071