Urodynamic

Main information

  • Trade name:
  • Urodynamic catheter
  • Class:
  • Class IIa
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Urodynamic catheter
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220182
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220182

Innologic Pty Ltd - Urodynamic catheter

ARTG entry for

Medical Device Included Class IIa

Sponsor

Innologic Pty Ltd

Postal Address

6 Gould Street,OSBORNE PARK, WA, 6017

Australia

ARTG Start Date

15/02/2014

Product category

Medical Device Class IIa

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Stericom Ltd

Unit 1 & 2 Higham Mead

Chesham, , HP5 2AH

Products

1. Urodynamic catheter

Product Type

Single Device Product

Effective date

15/02/2014

GMDN

55837 Urodynamic catheter

Intended purpose

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

single-use device.

Specific Conditions

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.

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:59:46 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