Summary for ARTG Entry:
Pacing Importers Pty Ltd - Finapres Nova - Patient monitoring system module, blood pressure, noninvasive
ARTG entry for
Medical Device Included Class IIa
Pacing Importers Pty Ltd
8-12 Alma Road,ST KILDA, VIC, 3182
ARTG Start Date
Medical Device Class IIa
- 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.
FMS Finapres Medical Systems BV
Amsterdam, , 1101 CC
1. Finapres Nova - Patient monitoring system module, blood pressure, noninvasive
Medical device system
36551 Patient monitoring system module, blood pressure, noninvasive
The Finapres Nova is a standalone device intended for desktop use. Measurements are to be performed
under uninterrupted patient surveillance of the operator.
The Finapres Nova is used in a professional medical environment (i.e. hospitals, clinics and research
institutions etc.). The Finapres Nova is suitable for use in an operating room in the non-sterile zone.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:18:19 AEDT
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