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Electronic insulin pen - ARTG 378335

Access comprehensive regulatory information for Electronic insulin pen in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 378335 and sponsored by Pfizer Australia Pty Ltd, manufactured by PHC Corporation in Japan. The device registration started on November 19, 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.

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TGA ARTG Official Data
Class IIa
ARTG 378335
Class IIa
Electronic insulin pen
ARTG ID: 378335
Good Name: Pfizer Australia Pty Ltd - Electronic insulin pen
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Intended Purpose

This device is an electrical, auto-injector that is used with a dedicated Dose Dispenser Cartridge (DDC) under a home healthcare environment. The injector is for the self-injection of a subcutaneous dose of Tumor-Necrosis Factor inhibitors in the DDC. Patients are separately prescribed the DDC by healthcare professionals.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
378335
Start Date
November 19, 2021
Effective Date
November 19, 2021
Manufacturer
Country
Japan
Address
2131-1 Minamigata Toon, Ehime, 791-0395