Basic male condom, Hevea-latex

Public Summary

Summary for ARTG Entry:

339532

BSB Global Holding Pty Ltd - Basic male condom, Hevea-latex

ARTG entry for

Medical Device Included Class IIb

Sponsor

BSB Global Holding Pty Ltd

Postal Address

Suite 73, 738 Burke Road, Camberwell, VIC, 3124

Australia

ARTG Start Date

15/07/2020

Product Category

Medical Device Class IIb

Status

Active

Approval Area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2

(Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for

relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence;

and civil penalties may apply.

Manufacturers

Name

Address

Medical Latex (Dua) Sdn Bhd

PLO 8 Senai Industrial Estate

Senai

81400 JOHOR BAHRU, ,

Malaysia

Products

1 . Basic male condom, Hevea-latex

Product Type

Single Device Product

Effective Date

15/07/2020

GMDN

45138 Basic male condom, Hevea-latex

Intended Purpose

The intended purpose of the device is for contraception or the prevention of sexually transmitted diseases.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

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Produced at 22.07.2020 at 09:17:08 AEST

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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