Summary for ARTG Entry:
Imaxeon Pty Ltd - Infusion pump, general-purpose
ARTG entry for
Medical Device Included Class Im
Imaxeon Pty Ltd
PO Box 6033,SILVERWATER, NSW, 1811
ARTG Start Date
Medical Device Class Im
- 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.
Tema Sinergie Srl
Via Malpighi 120
Faenza, Ravenna, 48018
1. Infusion pump, general-purpose
Single Device Product
13215 Infusion pump, general-purpose
The device is intended for the automatic dispensing of radiopharmaceuticals in syringes or vials for the
purpose of minimising the amount of radiopharmaceuticals absorbed by operators and guaranteeing the
sterility of the doses produced. The device consists of a peristaltic pump. An administration set connects
the pump to a mother radiopharmaceutical vial and then to a syringe. The syringe is filled, and dismounted
from the system to be used on a separate infusion pump.
No Specific Conditions included on Record
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Produced at 10.11.2017 at 04:10:39 AEDT
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