Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Omnigon Pty Ltd - Bag, colostomy, closed-ended, one-piece
ARTG entry for
Medical Device Included Class 1
Omnigon Pty Ltd
PO Box 5013,Burnley, VIC, 3132
ARTG Start Date
Medical Device Class 1
- 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
1. Bag, colostomy, closed-ended, one-piece
Single Device Product
31066 Bag, colostomy, closed-ended, one-piece
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.
No Specific Conditions included on Record
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Produced at 03.11.2017 at 05:30:25 AEDT
This is not an ARTG Certificate document.
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