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Medema A/S
Medema A/S
Enggårdvej 7
DK-7400 Herning
EC – Declaration of conformity
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
MC 1144
MC 1144 Low Rider
MC 1144 Child
Medema-A/S
..............................................
Klaus Smedegaard
General Manager
Rev. 2
User guide 2433-2019-B
Herning, 31. Mai 2022
MC 1144
Basic UDI-DI
5707299MC1144N3
5707299MC1144LRJA
5707299MC1144CHGT
10 of 92
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
Version 2.0.1/2022
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