DECLARATION OF CONFORMITY
Confinity NV, Dorp 16, 9830, Sint-Martens-Latem, Belgium
declares the following device in sole responsibility:
Brand name: Wellhealth
Product type: Upper Arm Electronic Blood Pressure Monitor
Item number: WH-UAEBPM
Complies with the following harmonization rules:
IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR.
2:2007 + A1:2012 (or IEC 60601-1: 2012 reprint)
IEC 60601-1-11:2015 (Second Edition) for use in conjunction with
IEC 60601-1:2005 (Third Edition) + A1:2012
IEC 80601-2-30: 2018 for use in conjunction with IEC 60601-1:2005,
AMD1:2012
Signed for and on behalf of:
Sint-Martens-Latem, Belgium - Nov 2022
A. Pappijn - Product Manager