Summary for ARTG Entry:
Innologic Pty Ltd - Urodynamic catheter
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.
Unit 1 & 2 Higham Mead
Chesham, , HP5 2AH
1. Urodynamic catheter
Single Device Product
55837 Urodynamic catheter
A sterile, flexible or semi-rigid tube designed for connection to urodynamic measuring equipment for
urodynamic examination of a patient. It is inserted into the rectum, vagina or bladder via the urethra or
non-surgically via a stoma for cystometry, to drain the bladder to facilitate measurement of urinary output,
and for urethral pressure and other urethral and voiding pressure examinations. It is available with various
lumens (e.g., single, double, triple) providing one or more openings at the distal end, and is calibrated in
increments to assist in positioning. It may be dedicated to a gas or water infusion technique. This is a
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:59:46 AEDT
This is not an ARTG Certificate document.
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