Australia TGA ARTG record

Prosthesis, internal, testicle

Australia TGA ARTG Registered Device · Coloplast Pty Ltd · Coloplast AS · Class IIb · Started December 01, 2023

Good Name: Coloplast Pty Ltd - Prosthesis, internal, testicle

Device classification

Risk Class: Class IIb
Product Type: Single Device Product
ARTG Category: General

Registration information

Start Date: December 01, 2023
Effective Date: December 01, 2023

Sponsor

Name: Coloplast Pty Ltd

Manufacturer

Name: Coloplast AS
Country: Denmark
Address: Holtedam 1, Humlebaek, 3050

Intended purpose

The Saline-Filled Testicular Prosthesis is used when cosmetic testicular replacement is indicated i.e. in the case of agenesis or following the surgical removal of a testicle.

About this record

Access comprehensive regulatory information for Prosthesis, internal, testicle in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Coloplast Pty Ltd, manufactured by Coloplast AS in Denmark. The device registration started on December 01, 2023.

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.