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OSMOMAT 050 User Guide
Version 1.1 (2011-10-12)
9.3 Classification of the IVD
The Gonotec OSMOMAT
®
050 colloid osmometer is a non-invasive in-vitro diagnostic product accord-
ing to EEC Directive 93/42 (Medical Devices Law). The OSMOMAT
®
050 colloid osmometer is not
named in Annex II, list A or B, of the Directive 98/79/EEC for in-vitro diagnostics. Compliance is de-
clared per Annex III. Number 6 of Annex II is disregarded, since the unit’s intended use does not in-
clude personal use.
9.4 EC Compliance Statement - OSMOMAT
®
050
Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
D-10553 Berlin
We hereby declare that the OSMOMAT
®
050 colloid osmometer complies with Directive 98/79/EEC.
Compliance is declared per Annex III of the Directive. The CE mark on the unit acknowledges this.
Date:
Signature of managing director:
9.5 Provisions of Certification
CE compliance requires that the unit is installed and operated in the manner described in this manual.
Any departure from the specifications or independent modifications of the unit without the express
consent of Gonotec GmbH may result in a violation of CE requirements. Such actions invalidate the
compliance statement and transfer responsibility to the originator of said actions.
Summary of Contents for OSMOMAT 050
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