Primo-Lacto - Breast pump support kit, single-use, non-sterile

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

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Available from:
Simple Solutions International Pty Ltd
Class:
Class 1
Authorization status:
Included
Authorization number:
290155

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Public Summary

Summary for ARTG Entry:

290155

Simple Solutions International Pty Ltd - Primo-Lacto - Breast pump support kit, single-use, non-sterile

ARTG entry for

Medical Device Included Class 1

Sponsor

Simple Solutions International Pty Ltd

Postal Address

PO Box 90,WEMBLEY, WA, 6913

Australia

ARTG Start Date

14/06/2017

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

Hangzhou Fushan Medical Appliances Co Ltd

No 1288 Jinxi South Road Linglong Industry

Park

Zhejiang Province, Lin'an, 311301

China

Products

1. Primo-Lacto - Breast pump support kit, single-use, non-sterile

Product Type

Medical device system

Effective date

14/06/2017

GMDN

61733 Breast pump support kit, single-use, non-sterile

Intended purpose

To enable mothers to collect colostrum effectively when expressing breastmilk. Breastfeeding support kit

used with or without a breast pump. The kit does not alter function and flow if a pump is used. The device

is a add on to existing pumps. If a breast pump is not used the funnel component is used for hand

expressing.

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 04:52:45 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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