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Medicine administration kit, percutaneous, medicated, single-use - ARTG 237858

Access comprehensive regulatory information for Medicine administration kit, percutaneous, medicated, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 237858 and sponsored by Pfizer Australia Pty Ltd, manufactured by Pfizer Manufacturing Belgium in Belgium. The device registration started on May 15, 2015.

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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Class IIa
ARTG 237858
Class IIa
Medicine administration kit, percutaneous, medicated, single-use
ARTG ID: 237858
Good Name: Pfizer Australia Pty Ltd - Medicine administration kit, percutaneous, medicated, single-use
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Intended Purpose

Single use device for intracavernosal self-administration of medicine. It is for the treatment of erectile dysfunction in adult males. It may also be used as adjunct to other diagnostic tests in the diagnosis of erectile dysfunction. The Caverject Procedure Pack is supplied with a vial containing Caverject powder for injection, a diluent syringe, needles and alcohol swabs. The Caverject Impulse Procedure Pack is supplied with a vial containing Caverject powder for injection, a diluent dual chamber cartridge, needles and alcohol swabs.

Device Classification
Risk Class
Class IIa
Product Type
Procedure Pack
ARTG Category
General
Registration Information
ARTG ID
237858
Start Date
May 15, 2015
Effective Date
May 15, 2015
Manufacturer
Country
Belgium
Address
Rijksweg 12, Puurs-Sint-Amands, 2870