Pure Global

Catheter, urological, condom

Access comprehensive regulatory information for Catheter, urological, condom in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is sponsored by Butler Family Trust, manufactured by Bioderm Inc in United States of America. The device registration started on March 24, 2015.

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.

Free Database
Powered by Pure Global AI
TGA ARTG Official Data
Class I
Class I
Catheter, urological, condom
Australia TGA ARTG Registered Device
Good Name: Butler Family Trust - Catheter, urological, condom
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Purpose

A completely external catheter that seals gently and securely to the tip of the penis using BioDerm’s proprietary hydrocolloid adhesive, XtraDerm™ . This revolutionary device is designed specifically for institutional and hospital use. The unique design of Safe n’ Dry® allows for easy connection to any leg or bedside bag. Why Safe n’ Dry® is the best option: Completely external design One Size Fits Most (OSFM) design Average wear time of 24+ hours Keeps men dry and comfortable Allows for intermittent catheterization with the device in place Replaces diapers, external male catheters and medically unnecessary Foley catheters Latex free and hypoallergenic

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
Start Date
March 24, 2015
Effective Date
March 24, 2015
Manufacturer
Country
United States of America
Address
12320 73rd Ct N, Largo, FL