Suction unit, breast pump, powered

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

Buy It Now

Available from:
Essentia Care Pty Ltd
Class:
Class IIa
Authorization status:
Included
Authorization number:
292829

Read the complete document

Public Summary

Summary for ARTG Entry:

292829

Essentia Care Pty Ltd - Suction unit, breast pump, powered

ARTG entry for

Medical Device Included Class IIa

Sponsor

Essentia Care Pty Ltd

Postal Address

11-15 Leicester Avenue,Glen Waverley, VIC, 3150

Australia

ARTG Start Date

15/08/2017

Product category

Medical Device Class IIa

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

Cimilre Co Ltd

97-14 Seongnam-ro Mokcheon-eup

Dongnam-gu Cheonan-si

, Chungcheongnam-do,

Korea - Republic of

Products

1. Suction unit, breast pump, powered

Product Type

Medical device system

Effective date

15/08/2017

GMDN

38478 Suction unit, breast pump, powered

Intended purpose

Powered breast pump intended to express and collect milk from the breasts of lactating women.

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 03.11.2017 at 07:02:17 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

Search alerts related to this product

Share this information