Bag, colostomy, closed-ended, one-piece

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

Buy It Now

Available from:
Omnigon Pty Ltd
Class 1
Authorization status:
Authorization number:

Read the complete document

Public Summary

Summary for ARTG Entry:


Omnigon Pty Ltd - Bag, colostomy, closed-ended, one-piece

ARTG entry for

Medical Device Included Class 1


Omnigon Pty Ltd

Postal Address

PO Box 5013,Burnley, VIC, 3132


ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Welland Medical Ltd

7/8 Brunei Centre Newton Road

Crawley, West Sussex, RH10 2TU

United Kingdom


1. Bag, colostomy, closed-ended, one-piece

Product Type

Single Device Product

Effective date



31066 Bag, colostomy, closed-ended, one-piece

Intended purpose

Aurum Profile Colostomy is intended to collect human faecal waste by attachment to the skin around a

stoma using an adhesive flange incorporating Manuka Honey. The flexible, mouldable flange is intended

for users with uneven skin around the stoma, such as a hernia.

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

Public Summary

Page 1 of

Produced at 03.11.2017 at 05:30:25 AEDT

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 for contact information

Search alerts related to this product

Share this information