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Zephyr Penile Implant - Prosthesis, internal, penile, inflatable

Access comprehensive regulatory information for Zephyr Penile Implant - Prosthesis, internal, penile, inflatable in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Profile Medical Devices Pty Ltd, manufactured by Zephyr Surgical Implants in Switzerland. The device registration started on July 24, 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.

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TGA ARTG Official Data
Class IIb
Class IIb
Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
Australia TGA ARTG Registered Device
Good Name: Profile Medical Devices Pty Ltd - Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
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Intended Purpose

The penile implant is a prosthesis designed to facilitate penile rigidity in patients with erectile dysfunction.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
July 24, 2019
Effective Date
July 24, 2019
Manufacturer
Country
Switzerland
Address
Route des jeunes 4 bis CH-1227 Les Acacias, Geneva