Australia flagARTG 482237

Zephyr Penile Implant - Prosthesis, internal, penile, rod

ARTG ID: 482237 · MHDU Operations Pty Ltd · Zephyr Surgical Implants · Class IIb · Started March 12, 2025

Good Name: MHDU Operations Pty Ltd - Zephyr Penile Implant - Prosthesis, internal, penile, rod

Device classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration information
ARTG ID
482237
Start Date
March 12, 2025
Effective Date
March 12, 2025
Sponsor
Manufacturer
Country
Switzerland
Address
Route des jeunes 4 bis CH-1227 Les Acacias, Geneva
Intended purpose

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

About this record

Access comprehensive regulatory information for Zephyr Penile Implant - Prosthesis, internal, penile, rod in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 482237 and sponsored by MHDU Operations Pty Ltd, manufactured by Zephyr Surgical Implants in Switzerland. The device registration started on March 12, 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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