Summary for ARTG Entry:
Karl Storz Endoscopy Australia Pty Ltd - Cystourethroscope, flexible, video
ARTG entry for
Medical Device Included Class IIa
Karl Storz Endoscopy Australia Pty Ltd
PO Box 50,LANE COVE, NSW, 1595
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.
Karl Storz GmbH & Co KG
TUTTLINGEN, Tuttlingen, D 78532
1. Cystourethroscope, flexible, video
Single Device Product
32019 Cystourethroscope, flexible, video
An endoscope used for observation, diagnosis, and treatment of the bladder and male urethra, including
prostate region. Its insertion portion is flexible. The image transmitting system is a videoscope with a
charge-coupled device (CCD) chip at the distal end.
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.
Page 1 of
Produced at 10.11.2017 at 03:31:35 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