Australia TGA ARTG record

Basic male condom, Hevea-latex

Australia TGA ARTG Registered Device · Get Down Pty Ltd · Karex Industries Sdn Bhd · Class IIb · Started December 03, 2020

Good Name: Get Down Pty Ltd - Basic male condom, Hevea-latex

Device classification

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

Registration information

Start Date: December 03, 2020
Effective Date: December 03, 2020

Sponsor

Name: Get Down Pty Ltd

Manufacturer

Name: Karex Industries Sdn Bhd
Country: Malaysia
Address: Lot 2244 Batu 39 1/2 Pontian Besar, Pontian, Johor, 82000

Intended purpose

Non-sterile Non-medicated Natural Rubber Latex Male Condom is used for contraception and prevention of sexually transmitted infections.

About this record

Access comprehensive regulatory information for Basic male condom, Hevea-latex in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Get Down Pty Ltd, manufactured by Karex Industries Sdn Bhd in Malaysia. The device registration started on December 03, 2020.

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.