Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Simple Solutions International Pty Ltd - Primo-Lacto - Breast pump support kit, single-use, non-sterile
ARTG entry for
Medical Device Included Class 1
Simple Solutions International Pty Ltd
PO Box 90,WEMBLEY, WA, 6913
ARTG Start Date
Medical Device Class 1
- 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.
Hangzhou Fushan Medical Appliances Co Ltd
No 1288 Jinxi South Road Linglong Industry
Zhejiang Province, Lin'an, 311301
1. Primo-Lacto - Breast pump support kit, single-use, non-sterile
Medical device system
61733 Breast pump support kit, single-use, non-sterile
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
No Specific Conditions included on Record
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Produced at 03.11.2017 at 04:52:45 AEDT
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