Manufacturer: Your ref.

Our ref. BLM/16-239

LifeScan Europe Tel. +31 88 96 83 009
A Division of Cilag GmbH Fax +31 88 96 83 100
International E-mail medical.global@dekra.com
Gubelstrasse 34
CH-6300 Zug
Switzerland

Arnhem, July 18, 2016

Subject: Statement Letter

To whom it may concern,

DEKRA Certification B.V. declares that the following mentioned products;

 OneTouch® Verio® Blood Glucose Monitoring System (serial number

prefixed with 'X')
 OneTouch® Verio™ Blood Glucose Monitoring System (serial number
prefixed with 'X')
 OneTouch® Verio® 2 Blood Glucose Monitoring System (serial
number prefixed with 'X')
 OneTouch® Verio® IQ Blood Glucose Monitoring System
 OneTouch® VerioVue™ Blood Glucose Monitoring System
 OneTouch® Select® Plus Blood Glucose Monitoring System
 OneTouch® Verio® FlexTM Blood Glucose Monitoring System
 OneTouch® Select Plus FlexTM Blood Glucose Monitoring System
 OneTouch® Ultra Plus FlexTM Blood Glucose Monitoring System

of LifeScan Europe, a division of Cilag GmbH International, fulfil the criteria according to
ISO 15197:2013 and EN ISO 15197:2015. This declaration is based on a review of which the
result is reported in review reports 2167017-TDR12-R1, 2174452-TDR14-R1, 2175841-TDR15-
R1, 2181643-TDR16-R1 and 2190331-TDR17-R1 respectively.

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem The Netherlands
T +31 88 96 83 009 F +31 88 96 83 100 medical.global@dekra.com www.dekra-certification.com
Registered Arnhem 09085396
 2 BLM/16-239

With kind regards,

DEKRA Certification B.V.

Ir. H. van der Woord

Project Manager Medical

DEKRA Certification B.V. Meander 1051, 6825 MJ Arnhem P.O. Box 5185, 6802 ED Arnhem The Netherlands
T +31 88 96 83 009 F +31 88 96 83 100 medical.global@dekra.com www.dekra-certification.com
Registered Arnhem 09085396