Australia TGA ARTG record

Basic male condom, Hevea-latex

Australia TGA ARTG Registered Device · Bosco Medical Australia · Karex Industries Sdn Bhd · Class IIb · Started April 13, 2021

Good Name: Bosco Medical Australia - Basic male condom, Hevea-latex

Device classification

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

Registration information

Start Date: April 13, 2021
Effective Date: April 13, 2021

Sponsor

Name: Bosco Medical Australia

Manufacturer

Name: Karex Industries Sdn Bhd
Country: Malaysia
Address: PTD 7906 & 7907 Taman Pontian Jaya Batu 34 Jalan Johor Pontian, Johor, 82000

Intended purpose

For contraception and the prevention of sexually transmitted diseases.

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 Bosco Medical Australia, manufactured by Karex Industries Sdn Bhd in Malaysia. The device registration started on April 13, 2021.

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.