Declaration Of Conformity - medemagroup Mini Crosser X2 4W Service Manual

Medema A/S
Service manual 1533-2002-S

Declaration of conformity

Model:
Medema-A/S declares on our sole responsibility that the product
range mentioned below are manufactured in accordance with our
incorporated standards and are in conformity with the following direc-
tives and standards if they are used according to our instructions:
Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 on medical devices.
EN 12184:2014 Electrically powered wheelchairs, scooters and
their chargers - Requirements and test methods
Risk analysed according to ISO 14971:2012, Medical devices –
Application of risk management to medical devices.
Type of use
Risk Class
The product range in the Mini Crosser model-X2 includes the fol-
lowing items
Product name
Mini Crosser X2 3W 10 km/h
Mini Crosser X2 3W 13 km/h
Mini Crosser X2 3W 15 km/h
Mini Crosser X2 4W 10 km/h
Mini Crosser X2 4W 13 km/h
Mini Crosser X2 4W 15 km/h
Mini Crosser X2 HD 4W 10 km/h
Mini Crosser X2 CAB 10 km/h
Mini Crosser X2 CAB 13 km/h
Mini Crosser X2 CAB 15 km/h
The Mini Crosser or parts (fx. batteries) af the Mini Crosser can,
for a fee, be taken to the nearest dealer for disposal in accordance
with current environmental regulations.
Manufacturer:
Address:
Tel.
Date: 16.03.2020
Mini Crosser X2
: Transporting walking disabled people
: I
Basic UDI-DI
5707299MCX2-3W106A
5707299MCX2-3W136G
5707299MCX2-3W156L
5707299MCX2-4W106H
5707299MCX2-4W136P
5707299MCX2-4W156T
5707299MCX2-4WHD105S
5707299MCX2-CAB10KA
5707299MCX2-CAB13KG
5707299MCX2-CAB15KL
Medema A/S
Enggårdvej 7, DK-7400 Herning
+45 7010 1755
Signature: _____________________
Managing director Finn Dose
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