Basic male condom, Hevea-latex

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
BSB Global Holding Pty Ltd
Class:
Class IIb
Authorization status:
Included
Authorization number:
339532

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

© Commonwealth of Australia. This work is copyright. You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth. Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

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.

Visit www.tga.gov.au for contact information

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