Australia TGA ARTG record

Tubing set, nebulizer

Australia TGA ARTG Registered Device · Medline International Two Australia Pty Ltd · Galemed Xiamen Co Ltd · Class IIb · Started September 28, 2023

Good Name: Medline International Two Australia Pty Ltd - Tubing set, nebulizer

Device classification

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

Registration information

Start Date: September 28, 2023
Effective Date: September 28, 2023

Sponsor

Name: Medline International Two Australia Pty Ltd

Manufacturer

Name: Galemed Xiamen Co Ltd
Country: China
Address: Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39 Section 3 Hajing East Road, Fujian Province, 361026

Intended purpose

Intended to be connected to a nebulizing system gas compressor or medical gas outlet to create/deliver an aerosol, usually medicated, to the patient's respiratory system. Pharmaceuticals are not included. This is a single-use device.

About this record

Access comprehensive regulatory information for Tubing set, nebulizer in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medline International Two Australia Pty Ltd, manufactured by Galemed Xiamen Co Ltd in China. The device registration started on September 28, 2023.

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.