Declarations of conformity according to MDR

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Since May 26, 2021, the new EU Medical Device Regulation (MDR) (EU 2017/745) is mandatory for medical device manufacturers. This replaces the Medical Device Directive (MDD) (93/42/EEC) which was valid until then.

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All declarations of conformity of our medical devices have been updated by the introduction of the MDR, according to its requirements.

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The declarations of conformity are available to you, as our certified customer, for download in the customer online portal.

 

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EUDAMED

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EUDAMED is the European database for medical devices. It serves the central administration of medical devices in the EU and is based on a resolution of the EU Commission (2010/227/EU) from the year 2010. Through the MDR (Medical Device Regulation (EU 2017/745)), we as manufacturers are obligated to provide informations about us and our products in the database.

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In EUDAMED we are registered under the following Single Registration Number (SRN):  DE-MF-000016437