Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
The O R Company Pty Ltd - Uterine manipulator
ARTG entry for
Medical Device Included (Export Only) Class 1
The O R Company Pty Ltd
1/32 Silkwood Rise,Carrum Downs, VIC, 3201
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.
Panpac Medical Corporation
6F-2 No 202 Sec 3 Ta-Tong Road
Shi-Chin District, New Taipei City, 221
Taiwan (Province of China)
1. Uterine manipulator
Single Device Product
58051 Uterine manipulator
Use of the Panpac Uterine Manipulator is indicated in Diagnostic Laparoscopy, Minilaparotomy, Fertility
Exams, and Salpingoplastic procedures where manipulation of the uterus is required.
No Specific Conditions included on Record
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Produced at 01.12.2017 at 06:52:09 AEDT
This is not an ARTG Certificate document.
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