Non-contact Forehead Infrared Thermometer

EC Certificate

Full Quality Assurance System
Directive 931421EEC on Medical Devices (MDD), Annex II excluding (4) (Devices in Class Ila, Ilb or Ill)
No. G1 093979 0005 Rev. 00

Manufacturer and Facility(ies) : ShenZhen Medek Bio-Medical Co., Ltd.
No.101 Wenhao Industrial Park No.13 Yuanxin Road
Tongle Community, Baolong Street Longgang District
518100 Shenzhen
PEOPLE’S REPUBLIC OF CHINA

Product Category(ies): Infrared Thermometer

The Certification Body of TUV SOD Product Service GmbH declares that the aforementioned manufacturer has implemented a quality assurance system for design, manufacture and final inspection of the respective devices / device categories in accordance with MDD Annex II. This quality assurance system conforms to the requirements of this Directive and is subject to periodical surveillance. For marketing of class III devices an additional Annex II (4) certificate is mandatory. See also notes overleaf.

Report No.: GZ1821801
Valid from: 2018-08-09
Valid until: 2021-09-08