Urethral

Main information

  • Trade name:
  • Urethral catheterization kit, drainage, single-administration, self-applied
  • Class:
  • Class Is
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Urethral catheterization kit, drainage, single-administration, self-applied
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218710
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218710

Coloplast Pty Ltd - Urethral catheterization kit, drainage, single-administration, self-applied

ARTG entry for

Medical Device Included Class Is

Sponsor

Coloplast Pty Ltd

Postal Address

PO Box 240,MOUNT WAVERLEY, VIC, 3149

Australia

ARTG Start Date

20/12/2013

Product category

Medical Device Class Is

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

Coloplast AS

Holtedam 1

Humlebaek, , DK 3050

Denmark

Products

1. Urethral catheterization kit, drainage, single-administration, self-applied

Product Type

Procedure Pack

Effective date

20/12/2013

GMDN

45605 Urethral catheterization kit, drainage, single-administration, self-applied

Intended purpose

EasiCath set is a single use, self applied, sterile urinary catheter integrated in bag for intermittent use in

males and females.

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 09:35:54 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

17-1-2018

TGA actions after review into urogynaecological surgical mesh implants

TGA actions after review into urogynaecological surgical mesh implants

Update - Stress Urinary Incontinence (SUI) mid-urethral slings

Therapeutic Goods Administration - Australia

There are no news related to this product.