Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Koala Medical Pty Ltd - Skin Stapler
ARTG entry for
Medical Device Included Class IIa
Koala Medical Pty Ltd
PO Box 1191,MONA VALE, NSW, 2103
ARTG Start Date
Medical Device Class IIa
- 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.
Xi'an Kaydee Medical Appliances Co Ltd
10101 Building 6 No 299 Second Industrial
Space Base, Xian, 710100
1. Skin Stapler
Single Device Product
46332 Skin Stapler
A sterile hand-held surgical instrument designed for the application of skin staples to approximate free
edges of skin from an incision or wound. This device, often pistol-like in design, is typically loaded with
staples and is intended to mechanically deliver staples with manual power. This is a single-use device.
© 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.
Page 1 of
Produced at 02.11.2019 at 07:11:14 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 www.tga.gov.au for contact information