Radioisotope calibration system for diagnostic or therapeutic radiopharmaceuticals - Radioisotope calibration system

Australia - English - Department of Health (Therapeutic Goods Administration)

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Available from:
Global Medical Solutions Australia Pty Limited
Class:
Class Im
Authorization status:
Included
Authorization number:
324000

Public Summary

Summary for ARTG Entry:

324000

Global Medical Solutions Australia Pty Limited - Radioisotope calibration system for diagnostic or

therapeutic radiopharmaceuticals - Radioisotope calibration system

ARTG entry for

Medical Device Included Class Im

Sponsor

Global Medical Solutions Australia Pty Limited

Postal Address

GPO Box 115,ARNCLIFFE, NSW, 2205

Australia

ARTG Start Date

25/09/2019

Product category

Medical Device Class Im

Status

Active

Approval area

Medical Devices

Conditions

- 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.

Manufacturers

Name

Address

Comecer Netherlands BV

Madame Curieweg 1

, XC Joure, 8501

Netherlands

Products

1. Radioisotope calibration system for diagnostic or therapeutic radiopharmaceuticals - Radioisotope

calibration system

Product Type

Medical device system

Effective date

25/09/2019

GMDN

40738 Radioisotope calibration system

Intended purpose

Radioisotope Calibration System for diagnostic or therapeutic radio-pharmaceuticals.

Specific Conditions

© 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 http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 02.11.2019 at 03:52:12 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.

Visit www.tga.gov.au for contact information

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