Sterilizer

Main information

  • Trade name:
  • Sterilizer, gas, formaldehyde
  • Class:
  • Class IIb
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • Sterilizer, gas, formaldehyde
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218895
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218895

Babich Maintenance & Steriliser Services Pty Ltd - Sterilizer, gas, formaldehyde

ARTG entry for

Medical Device Included Class IIb

Sponsor

Babich Maintenance & Steriliser Services Pty Ltd

Postal Address

PO Box 3480,SUCCESS, WA, 6964

Australia

ARTG Start Date

3/01/2014

Product category

Medical Device Class IIb

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

BMM Weston Limited

Weston Works

Brent Hill Faversham, Kent, ME13 7BE

Products

1. Sterilizer, gas, formaldehyde

Product Type

Single Device Product

Effective date

3/01/2014

GMDN

40583 Sterilizer, gas, formaldehyde

Intended purpose

Low temperature Steam Formaldehyde Steriliser, used for the low temperature sterilisation of reusable

medical instruments and equipment that are heat sensitive and therefore require a lower temperature to be

used during the sterilisation process

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 09:01:41 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