Insulin syringe, fixed-needle - ARTG 354928
Access comprehensive regulatory information for Insulin syringe, fixed-needle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 354928 and sponsored by Icon International Pty Ltd t/a Icon Medipharm, manufactured by Jiangyin Nanquan Macromolecule Product Co Ltd in China. The device registration started on February 15, 2021.
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.
A sterile device consisting of a calibrated barrel (cylinder) with plunger, with a permanently-attached needle (usually capped for user protection), intended to be used to administer an injection of insulin to a patient subcutaneously. It is typically made of plastic and silicone materials and will have plunger anti-sticking properties (internally coated with compatible substances) allowing smooth plunger movement. It can be used by healthcare personnel or patients, and will allow for the aspiration of the pharmaceutical from its container for direct administration to the patient or via an intravenous (IV) port, heparin lock, or saline lock. This is a single-use device.