Declaration Of Conformity - Medema Mini Crosser M2 Service Manual

Medema A/S
Service manual P9-0157-S

Declaration of conformity

Medema A/S hereby declares that:
Machine:
Use:
Model No:
Complies with the Medical Device Directive 93/42/EEC
The product is made in accordance with the harmonized
standard EN 12184 - Electrically powered wheelchairs, scooters
and their chargers.
The product is risk analysed in accordance with the harmonized
standard DS/EN ISO 14971:2007-04-10 2. edition - Medical
devices - Application of risk management to medical devices.
Mini Crosser scooters can, for a fee, be taken to the nearest
dealer for disposal in accordance with current environmental
regulations.
Manufacturer:
Address:
Tel./Fax
Date: 02.01.2014
Mini Crosser
(Prescribed use in
User Manual)
M2
Medema A/S
Enggårdvej 7, DK-7400 Herning
+45 7010 2054
Signature: _____________________
10 of 70
+45 9716 8582
Version 2.0.9 - 2018