ARTG 458107Ambulatory nebulizer, non-heated
ARTG ID: 458107 · Aero Healthcare · Hunkar Eza ve Medikal Sanayi ve Ticaret Limited Sirketi · Class IIb · Started August 01, 2024
Good Name: Aero Healthcare - Ambulatory nebulizer, non-heated
- Risk Class
- Class IIb
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 458107
- Start Date
- August 01, 2024
- Effective Date
- August 01, 2024
- Name
- Aero Healthcare
- Country
- Turkey
- Address
- Akcesme Mahallesi 2019 Sokak No:5 Merkezefendi, Denizli
The intended use of the device is for the treatment/management of respiratory diseases (eg asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF). It produces non-heated aerosolized humidification or medication for a patient to inspire. It is combined with piezo, which converts electric energy into mechanical energy and has an active vibrating mesh technology. It is hand-held, portable device designed for use at home, at work, and when travelling.
Access comprehensive regulatory information for Ambulatory nebulizer, non-heated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 458107 and sponsored by Aero Healthcare, manufactured by Hunkar Eza ve Medikal Sanayi ve Ticaret Limited Sirketi in Turkey. The device registration started on August 01, 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.