We, the manufacturer:
Medema Production A/S
Enggårdvej 7
DK-7400 Herning
Tel: (+45) 70 10 20 54
Fax: (+45) 97 16 85 82
Hereby declares that the product:
MC 1122
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.
Title: R&D Manager
Name: Klaus Smedegaard
Date: 20/12-2012 Signature:___________________________________
User guide P9-0222-B
9 of 64
Version 1.0.9/2015
Medema A/S
Declaration of conformity
Medema Production A/S hereby declares that:
Machine: MC
Use:
(Prescribed use in
User Manual)
Model No:
1122
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.
The Mini Crosser can, for a fee, be taken to the nearest
dealer for disposal in accordance with current environmental
regulations.
Manufacturer:
Medema Production A/S
Address:
Enggårdvej 7, DK-7400 Herning
Tel./Fax
+45 7010 2054 +45 9716 8582
Date: 20.12.2012
Signature: _____________________
