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Zephyr Penile Implant - Prosthesis, internal, penile, inflatable - ARTG 477625

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 registered under ARTG number 477625 and sponsored by MHDU Operations Pty Ltd, manufactured by Zephyr Surgical Implants in Switzerland. The device registration started on February 04, 2025.

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 IIb
ARTG 477625
Class IIb
Zephyr Penile Implant - Prosthesis, internal, penile, inflatable
ARTG ID: 477625
Good Name: MHDU Operations 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
ARTG ID
477625
Start Date
February 04, 2025
Effective Date
February 04, 2025
Manufacturer
Country
Switzerland
Address
Route des jeunes 4 bis CH-1227 Les Acacias, Geneva