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Certified Quality EN ISO 13485:2016
The compliance with the Directive 98/79/EC regarding in vitro diagnostics and the related national regulations is a matter of course for Seramun. Our In-vitro diagnostics are CE marked. In addition, we adhere to further internationally applicable standards in order to strengthen our market position and explore new spheres of Business.
EU Certification - REGULATION (EU) 2017/746 on In Vitro Diagnostic Medical Devices
With the certification of our IVR 0503 (W01050104 - HELICOBACTER PYLORI) and IVR 0602 (W01021004 - VASCULITIS) products, another milestone has been reached in the field of regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices. This enables us to further expand our versatile product portfolio and strongly support our customers in a competitive manner.