Main information

  • Trade name:
  • Infusion pump, general-purpose
  • Class:
  • Class Im
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device



  • Available in:
  • Infusion pump, general-purpose
  • Language:
  • English

Other information


  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 216816
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:


Imaxeon Pty Ltd - Infusion pump, general-purpose

ARTG entry for

Medical Device Included Class Im


Imaxeon Pty Ltd

Postal Address

PO Box 6033,SILVERWATER, NSW, 1811


ARTG Start Date


Product category

Medical Device Class Im



Approval area

Medical Devices


- 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

Product Type

Single Device Product

Effective date



13215 Infusion pump, general-purpose

Intended 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.

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at

Public Summary

Page 1 of

Produced at 10.11.2017 at 04:10:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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