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7.3 EC Declaration of conformity
This declaration of conformity is issued under the sole responsibility of the
manufacturer:
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
This declaration relates exclusively to the machinery in the state in which it was
placed on the market, and excludes components which are added and/or
operations carried out subsequently by the final user.
The declaration of conformity refers to the machinery identified as follows:
Description: Laboratory equipment
Model: CliniMACS Formulation Unit
The machinery complies with all essential requirements of the following
directives:
2006/42/EC Machinery
2011/65/EU Restriction of the use of certain hazardous substances in
electrical & electronic equipment
2014/30/EU Electromagnetic compatibility
The machinery is in conformity with the following harmonized standards:
EN 61010-1:2010
EN 60601-1-2:2015
Person authorized to compile the relevant technical documentation:
Dr. Bernd Schröder
Global Head Regulatory Affairs
Miltenyi Biotec B.V. & Co. KG
Friedrich-Ebert-Straße 68
51429 Bergisch Gladbach
Germany
