Enema Bag - Manual enema device

Australia - English - Department of Health (Therapeutic Goods Administration)

Buy It Now

Available from:
Happy Bum Co
Class:
Class 1
Authorization status:
Included
Authorization number:
323159

Public Summary

Summary for ARTG Entry:

323159

Happy Bum Co - Enema Bag - Manual enema device

ARTG entry for

Medical Device Included Class 1

Sponsor

Happy Bum Co

Postal Address

252 Mooroondu Road,Thorneside, QLD, 4185

Australia

ARTG Start Date

13/09/2019

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

Ningbo Albert Novosino Co Ltd

No1 Xinheng 3 Road Cicheng Town

Jiangbei District, Ningbo, 315036

China

Products

1. Enema Bag - Manual enema device

Product Type

Medical device system

Effective date

13/09/2019

GMDN

60825 Manual enema device

Intended purpose

Gently wash the colon with purified water via the rectum for personal use.

Specific Conditions

© 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 08.11.2019 at 10:46:54 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

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