GE AKTAprime plus Operating Instructions Manual page 8

1 Introduction
1.2 Regulatory information
Manufacturing information
The table below summarizes the required manufacturing information. For further infor-
mation, see the EC Declaration of Conformity document.
Requirement
Name and address of
manufacturer
CE conformity
This product complies with the European directives listed in the table, by fulfilling the
corresponding harmonized standards.
A copy of the EC Declaration of Conformity is available on request.
Directive
2006/42/EC
2006/95/EC
2004/108/EC
CE marking
The CE marking and the corresponding Declaration of Conformity is valid for the instru-
ment when it is:
•
•
•
•
8
used as a stand-alone unit, or
connected to other CE marked instruments, or
connected to other products recommended or described in the user documentation,
and
used in the same state as it was delivered from GE Healthcare, except for alterations
described in the user documentation.
Content
GE Healthcare Bio-Sciences AB, Björkgatan 30,
SE-751 84 Uppsala, Sweden
Title
Machinery Directive (MD)
Low Voltage Directive (LVD)
Electromagnetic Compatibility (EMC) Directive
ÄKTAprime plus Operating Instructions 28-9597-89 AB