medemagroup MC 1124 Adult, User Manual

Page: 10 / 92

User guide 2433-2019-B 10 of 92 Version 2.0.1/2022
Medema A/S
Medema A/S
Enggårdvej 7
Snejbjerg
7400 Herning
CVR/VAT: DK 51 89 27 12
SRN: DK-MF-000000981
Phone: 70 10 17 55
info@medema.com
www.medema.com
Rev. 2
Medema A/S
Enggårdvej 7
DK-7400 Herning
Herning, 31. Mai 2022
EC – Declaration of conformity
MC 1144
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 directives 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.
Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on
machinery, and amending Directive 95/16/EC.
Directive 2011/65/EU of the European Parliament and of the council of 8 June 2011 on the
restriction of the use of certain hazardous substances in electrical and electronic
equipment.
DS/EN IEC 63000:2018 Technical documentation for the assessment of electrical and
electronic products with respect to the restriction of hazardous substances.
ISO 14971:2019 Medical devices – Application of risk management to medical devices.
Type of use : Transporting walking disabled people.
Risk Class : 1 according to rule 1.
The product range in the
MC 1144
includes the following items:
Product name Basic UDI-DI
MC 1144 5707299MC1144N3
MC 1144 Low Rider 5707299MC1144LRJA
MC 1144 Child 5707299MC1144CHGT
Medema-A/S
……………………………………….
Klaus Smedegaard
General Manager