Australia TGA ARTG record

Catheter, urological, condom

Australia TGA ARTG Registered Device · Butler Family Trust · Bioderm Inc · Class I · Started March 24, 2015

Good Name: Butler Family Trust - Catheter, urological, condom

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

Sponsor

Name: Butler Family Trust

Manufacturer

Name: Bioderm Inc
Country: United States of America
Address: 12320 73rd Ct N, Largo, FL

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

About this record

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.