Urodynamic

Main information

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

Documents

Localization

  • Available in:
  • Urodynamic measurement system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216828
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

216828

Innologic Pty Ltd - Urodynamic measurement system

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

1/11/2013

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

Medkonsult sro

Balcarkova 1258/8

, Olomouc, 779 00

Czech Republic

Products

1. Urodynamic measurement system

Product Type

Single Device Product

Effective date

1/11/2013

GMDN

14307 Urodynamic measurement system

Intended purpose

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.

Specific Conditions

No Specific Conditions included on Record

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Public Summary

Page 1 of

Produced at 10.11.2017 at 04:08:20 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