ARTG 327875Basic insulin pen, replaceable-cartridge
ARTG ID: 327875 · Gedeon Richter Australia Pty Ltd · Ypsomed AG · Class IIa · Started December 18, 2019
Good Name: Gedeon Richter Australia Pty Ltd - Basic insulin pen, replaceable-cartridge
- Risk Class
- Class IIa
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 327875
- Start Date
- December 18, 2019
- Effective Date
- December 18, 2019
- Name
- Ypsomed AG
- Country
- Switzerland
- Address
- Brunnmattstrasse 6, Burgdorf, Switzerland, 3401
A portable, hand-held, mechanical device in the form of a large pen, designed to accept a pharmaceutical-containing cartridge and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and a dial on the device is operated for dosing. The cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.
Access comprehensive regulatory information for Basic insulin pen, replaceable-cartridge in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 327875 and sponsored by Gedeon Richter Australia Pty Ltd, manufactured by Ypsomed AG in Switzerland. The device registration started on December 18, 2019.
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.