Summary for ARTG Entry:
Analytica Ltd - Perineometer
ARTG entry for
Medical Device Included Class 1
GPO Box 670,BRISBANE, QLD, 4001
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.
320 Adelaide Street
BRISBANE, QLD, 4000
Medical device system
The device may be used to assist in the correction of urinary incontinence by means of exercise. It may
also be used by a health care practitioner to assist in the diagnosis and monitoring of urinary incontinence.
The device consists of a rigid probe for temporary intravaginal use which offers resistance to a patient's
voluntary pelvic floor muscle contractions and can provide an indication of the strength of these muscles.
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 03:12:01 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