Summary for ARTG Entry:
Carl Zeiss Pty Ltd - Electrosurgical system handpiece, foot-controlled, reusable
ARTG entry for
Medical Device Included Class IIb
Carl Zeiss Pty Ltd
PO Box 501,NORTH RYDE BC, NSW, 1670
ARTG Start Date
Medical Device Class IIb
- 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.
Carl Zeiss Meditec AG
Goeschwitzer Strasse 51-52
Jena, , D-07745
1. Electrosurgical system handpiece, foot-controlled, reusable
Single Device Product
44677 Electrosurgical system handpiece, foot-controlled, reusable
This active re-usable device is an accessory for Carl Zeiss phaco systems. It has been designed to
cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment.
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 04:48:46 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