Declarations of conformity

DiaSys GmbH was one of the first manufacturers declaring in 2000 conformity with directive 98/79/EC for In-Vitro-Diagnostics.

The declaration of conformity for reagents covers all reagents running on analyzers from third-party manufacturers as listed in the DiaSys product catalogue.

For all DiaSys analyzers of the respons® series as well as for Stardust FC/MC, SensoStar and InnovaStar® separate CE-declarations cover the respective parameters available.

For reagents for specific systems marketed by us as cooperation partner of a manufacturer (eg JCA BioMajesty® 6010/C), you will find in addition to the CE declaration of the manufacturer a separate declaration of conformity with approved parameters.

Updated declarations of conformity will be available immediately on this page.

Downloads of declarations of conformity

List of applied standards
Amendment to Conformity Declaration

Reagents
JCA-BioMajesty® 6010/C Analyzer 
InnovaStar^®  
respons®240c
respons®420c
respons®420c with ISE
respons®600c
respons®c-line cleaner
respons®910
respons®920
respons®940
respons®A1c analyzer
respons®A1c test kit
SensoStar GL30 touch
SensoStar GLH six