Main information

  • Trade name:
  • Enzymatic detergent, multiple enzyme
  • Class:
  • Class 1
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Enzymatic detergent, multiple enzyme
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221113
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


AE Atherton & Sons Pty Ltd - Enzymatic detergent, multiple enzyme

ARTG entry for

Medical Device Included Class 1


AE Atherton & Sons Pty Ltd

Postal Address

364 Darebin Road,



ARTG Start Date


Product category

Medical Device Class 1



Approval area

Medical Devices


- 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.




Schulke & Mayr GmbH

Robert-Koch-Strasse 2

, Norderstedt, 22851



1. Enzymatic detergent, multiple enzyme

Product Type

Single Device Product

Effective date



47530 Enzymatic detergent, multiple enzyme

Intended purpose

Detergent to remove most forms of organic proteinaceous matter from reusable medical/surgical devices

and apparatus such as endoscopes and

lumen during machine cleaning. Designed for ultrasonics, cleaners, and washers. After application, this

device cannot be reused.

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 02:10:42 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


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