Filter

Main information

  • Trade name:
  • Filter, steam, delivery line
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Filter, steam, delivery line
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 220260
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

220260

Majac Medical Products Pty Ltd - Filter, steam, delivery line

ARTG entry for

Medical Device Included Class 1

Sponsor

Majac Medical Products Pty Ltd

Postal Address

PO Box 74,VIRGINIA, QLD, 4014

Australia

ARTG Start Date

19/02/2014

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

SP Medikal San Ltd

Topcular Mah Incirlik Sokak Ertas Is Merkezi

No 5/56 Kat 2 Rami Eyup

Istanbul, ,

Turkey

Products

1. Filter, steam, delivery line

Product Type

Single Device Product

Effective date

19/02/2014

GMDN

35450 Filter, steam, delivery line

Intended purpose

Container filter round / square with indicator for sterilisation

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 04:44:12 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

22-8-2018

Santevia Water System Inc. recalls PureEasy Shower Filter

Santevia Water System Inc. recalls PureEasy Shower Filter

The housing can unexpectedly separate releasing the mineral contents into the eyes.

Health Canada

27-10-2017

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