Pure Global

Medicine administration kit, percutaneous, medicated, single-use

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 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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TGA ARTG Official Data
Class IIa
Class IIa
Medicine administration kit, percutaneous, medicated, single-use
Australia TGA ARTG Registered Device
Good Name: Pfizer Australia Pty Ltd - Medicine administration kit, percutaneous, medicated, single-use
Pure Global
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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
Start Date
May 15, 2015
Effective Date
May 15, 2015
Manufacturer
Country
Belgium
Address
Rijksweg 12, Puurs-Sint-Amands, 2870