8
3.
EC Declaration of Conformity
As manufacturer of the
LEVO
range of stand-up wheelchairs, the company
LEVO AG
Anglikerstrasse 20
CH-5610 Wohlen
Switzerland
declares under its sole responsibility that the Stand-up Wheelchair model
LEVO
LCM2
UDI-DI 7613045LCM2YR
Product Class I
conforms to the provisions of the Medical Device Regulation (EU) 745/2017.
This Declaration of Conformity
includes all accessories and options of the
LEVO
LCM2
and is according to Annex IV of Regulation (EU) 745/2017.
The
LEVO LCM2
is certified according to EN 12184:2014 by TüV-Sud and is
confirmed as crash tested under ISO 7176-19:2008 for use as a seat in motor
vehicles.
The EU Authorised Representative will be named before the 26
th
of May, 2021
corresponding with Regulation (EU) 745/2017 and this certificate amended
accordingly.
Wohlen, 2021-01-22
LEVO AG