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Prosthesis, internal, testicle - ARTG 429430

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 registered under ARTG number 429430 and 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.

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TGA ARTG Official Data
Class IIb
ARTG 429430
Class IIb
Prosthesis, internal, testicle
ARTG ID: 429430
Good Name: Coloplast Pty Ltd - Prosthesis, internal, testicle
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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.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
429430
Start Date
December 01, 2023
Effective Date
December 01, 2023
Manufacturer
Country
Denmark
Address
Holtedam 1, Humlebaek, 3050