Summary for ARTG Entry:
Endotherapeutics Pty Ltd - Foetal membrane manipulator
ARTG entry for
Medical Device Included Class Is
Endotherapeutics Pty Ltd
PO Box 673,EPPING, NSW, 1710
ARTG Start Date
Medical Device Class Is
- 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.
Yushin Medical Co Ltd
36 Jomaru-ro 427beon-gil Wonmi-gu
Bucheon-si, Gyeonggi-do, 420837
Korea - Republic of
1. Foetal membrane manipulator
47978 Foetal membrane manipulator
A sterile device used to atraumatically mechanically push and position an exposed or prolapsed foetal
membrane secondary to an incompetent cervix back through the cervical canal and into the uterus to
facilitate the surgical placement of a cervical cerclage in order to prolong pregnancy to a successful live
delivery. This is a single-use device.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 08:51:34 AEDT
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