Australia - English - Department of Health (Therapeutic Goods Administration)
Summary for ARTG Entry:
Hologic (Australia & New Zealand) Pty Ltd - Hysteroscopic irrigation/distention system
ARTG entry for
Medical Device Included Class IIb
Hologic (Australia & New Zealand) Pty Ltd
PO Box 1971,MACQUARIE CENTRE, NSW, 2113
ARTG Start Date
Medical Device Class IIb
- 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.
250 Campus Drive
Marlborough, MA, 01752
United States Of America
1. Hysteroscopic irrigation/distention system
Single Device Product
36122 Hysteroscopic irrigation/distention system
The Fluent® Fluid Management System is intended to provide liquid distension of the uterus during
diagnostic and operative hysteroscopy, and to monitor the volume differential between the irrigation fluid
flowing into and out of the uterus. The Fluent Fluid Management System is designed to be used in
operating room, ambulatory surgical center, and physician's office environments.
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Produced at 02.11.2019 at 03:34:08 AEDT
This is not an ARTG Certificate document.
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