CE Mark Certificate

EC Certificate

Full Quality Assurance System
Directive 93/42/EEC on Medical Devices (MDD), Annex II excluding (4)
(Devices in Class IIa, IIb or III)

No. G1 099651 0003 Rev. 00

Manufacturer:

TriMedika Ltd

Unit 3 E3 Building, Springvale Campus
398 Springfield Road
Co Antrim
Belfast, Northern Ireland, BT12 7DU
UNITED KINGDOM

Product Category(ies): Infra Red Thermometers for Clinical use

The Certification Body of TÜV SÜD 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.: 75947171

Valid from: 2020-03-27
Valid until: 2024-05-26

Date, 2020-03-27

Christoph Dicks

Head of Certification/Notified Body

Page 1 of 1

TÜV SÜD Product Service GmbH is Notified Body with identification no. 0123

TÜV SÜD Product Service GmbH • Certification Body • Ridlerstraße 65 • 80339 Munich • Germany

Official Document – EC-Certificate-New-Address.pdf