Summary for ARTG Entry:
Innologic Pty Ltd - Urodynamic measurement system
ARTG entry for
Medical Device Included Class IIa
Innologic Pty Ltd
6 Gould Street,OSBORNE PARK, WA, 6017
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.
, Olomouc, 779 00
1. Urodynamic measurement system
Single Device Product
14307 Urodynamic measurement system
A family of systems used for advanced diagnosis/study of the bladder. They are used to identify the cause
of abnormal voiding, including incontinence and are useful for the diagnosis of, e.g. neurogenic bladder
diseases, stress incontinence, urinary path obstruction or spastic sphincters. A diagnostic urodynamic
evaluation consists of uroflowmetry (measurement of urinary flow rate), urethral pressure profilometry
(measurement of urethral pressure), gas or water cystometry (measurement of bladder capacity and
response), and electromyogram (EMG) recording (the measurement of sphincter and other muscle
activity). Long-term recording may also be analysed.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:08:20 AEDT
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