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User guide P9-0133-B
8 of 62
Version 2.0.5 - 2015
Medema A/S
Declaration of conformity
Medema A/S hereby declares that:
Machine: Mini
Crosser
Use:
(Prescribed use in
User
Manual)
Model No:
M1 HD
Complies with the Medical Device Directive 93/42/EEC
The product is made in accordance with the harmonized
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Crossers 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.
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dealer for disposal in accordance with current environmental
regulations.
Manufacturer: Medema
A/S
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Tel./Fax
+45 7010 2054 +45 9716 8582
Date: 01.05.2014
Signature: _____________________