Appendix
Classification of the IVD
The cryoscopic osmometer Osmomat
®
auto manufactured by Gonotec is a non-invasive in-vitro
diagnostic product according to EEC Directive 93/42 (Medical Devices Law). The cryoscopic
osmometer Osmomat
®
auto is not named in Annex II, list A or B, of the Directive 98/79/EEC for in-vitro
diagnostic devices. Compliance is declared per Annex III. Number 6 of Annex II is disregarded, since
the unit’s intended use does not include personal use.
EC Compliance Statement—OSMOMAT
®
auto
Gonotec GmbH
GSG-Hof Reuchlinstr. 10-11
10553 Berlin / Germany
We hereby declare that the cryoscopic osmometer OSMOMAT
®
auto complies with Directive
98/79/EEC. Compliance is declared per Annex III of the Directive. The CE mark on the unit
acknowledges this.
Date: 10/24/2009
Signature of managing director: ........................................
Provisions of Certification
CE compliance requires that the unit be 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.
Appendix
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