Summary for ARTG Entry:
Regional Health Care Group Pty Ltd - Empower Systems - Angiography contrast medium injection system,
ARTG entry for
Medical Device Included Class IIb
Regional Health Care Group Pty Ltd
PO Box 151,ROSEBERY, NSW, 1445
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.
Bracco Injeneering S A
Avenue de Sevelin 46
, Lausanne, 1004
1. Empower Systems - Angiography contrast medium injection system, line-powered, stationary
Medical device system
57998 Angiography contrast medium injection system, line-powered, stationary
Intended to be used for controlled infusion of radiographic contrast media for angiographic procedures.
Used in conjunction with consumables such as syringe kits etc
No Specific Conditions included on Record
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Produced at 09.11.2017 at 09:53:05 AEDT
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