Bath

Main information

  • Trade name:
  • Bath, sitz
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Bath, sitz
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222847
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222847

Polymedic Pty Ltd - Bath, sitz

ARTG entry for

Medical Device Included Class 1

Sponsor

Polymedic Pty Ltd

Postal Address

PO Box 252,ASHMORE CITY, QLD, 4214

Australia

ARTG Start Date

28/04/2014

Product category

Medical Device Class 1

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

Polymedic Pty Ltd

Unit 1/ 397-401 Nerang Southport Road

ASHMORE, QLD, 4214

Australia

Products

1. Bath, sitz

Product Type

Single Device Product

Effective date

28/04/2014

GMDN

13609 Bath, sitz

Intended purpose

A therapeutic sit in bath for the patient to bath with the buttocks and abdominal region immersed in water.

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 09.11.2017 at 07:30:18 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

22-2-2019

IKERE Limited recalls ZOOCCHINI UPF50 Baby Cover up

IKERE Limited recalls ZOOCCHINI UPF50 Baby Cover up

As the Baby Cover up is advertised as a bathrobe, it must meet the flammability requirements for children's sleepwear. This product fails to meet these requirements. As a beach robe / cover-up it is not subject to the Children Sleepwear Regulations.

Health Canada

3-1-2019

Norwex Canada Recalls Bathroom Cleaner

Norwex Canada Recalls Bathroom Cleaner

Health Canada has determined that the recalled product does not meet the chemical hazard labelling and child-resistant packaging for consumer products as set out in the Consumer Chemicals and Containers Regulations, 2001 under the Canada Consumer Product Safety Act.

Health Canada

16-10-2018

Abond Group Inc. recalls Tubeez Baby Bath Support

Abond Group Inc. recalls Tubeez Baby Bath Support

The bath support’s suction cups may not adhere to the bath surface, making it unstable and cause it to possibly tip over while in use. In addition, an infant can slip underneath the front support bar and become lodged under water posing a drowning hazard.

Health Canada

There are no news related to this product.