Australija - anglų - Department of Health (Therapeutic Goods Administration)
01-11-2019
Public Summary
Summary for ARTG Entry:
322496
Philips Electronics Australia Ltd - Probe, thermometer, single use
ARTG entry for
Medical Device Included (Export Only) Class 1
Sponsor
Philips Electronics Australia Ltd
Postal Address
Locked Bag 30,NORTH RYDE BC, NSW, 1670
Australia
ARTG Start Date
30/08/2019
Product category
Medical Device Class 1
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
Philips Medical Systems
3000 Minuteman Road
Andover, Massachusetts, 01810-1099
United States Of America
Products
1. Probe, thermometer, single use
Product Type
Single Device Product
Effective date
30/08/2019
GMDN
35254 Probe, thermometer, single use
Intended purpose
Intended for continuous monitoring of body temperature.
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 05:37:05 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