Certificates

elem6 s.r.o.
Braskovska 15/308
161 00 Praha 6
Czech Republic
DECLARATION OF CONFORMITY
We, elem6 s.r.o.,
declare, under our sole responsibility, that the product
Product name: TrueLife
Model No.: Care Q7
Serial No.: TLCQ7YYMMXX
(TLCQ7 = prefix, YY = production year, MM = production month, XX = batch number)
we are the importer of to the EU, has been tested with the listed standards and found in
compliance with the Medical Devices Directive 93/42/EEC .
This declaration was issued based on EC certificate prepared by:
TÜV Rheinland LGA Products GmbH
Tillystraße 2
90431 Nürnberg, Germany
Certificate No.: DD 60128231 0001
Test Standards: IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012)
EN 60601-1:2006+A11:2011+A1: 2013+A12:2014
IEC/EN 60601-1-11:2015
ISO 80601-2-56:2017
EN ISO80601-2-56:2017
0197
Prague, Czech Republic, January 16, 2020
Miloš Brejcha
COO