Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
CoreMed Pty Ltd - Prosthesis, ossicular
ARTG entry for
Medical Device Included Class IIb
CoreMed Pty Ltd
PO Box 565,BALMAIN, NSW, 2041
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.
Spiggle & Theis Medizintechnik GmbH
Overath, , 51491
1. Prosthesis, ossicular
Single Device Product
35690 Prosthesis, ossicular
For reconstructing a total or partial destroyed middle-ear ossicular chain (chain of sound transmission)
between the footplate of the stirrup bone or the stapes, and the plane of the eardrum or tympanic
membrane level. Or for reconstruction of the sound conduction chain between middle ear and inner ear
through replacement of the stapes.
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 03.11.2017 at 02:51:26 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