Certificates

Certificates

Sweden has since 1993 a comprehensive law that specifies requirements for medical devices placed on the market. The base of this regulation is available in the act (1993:584) concerning medical devices and the regulations published by the Medical Products Agency. Our certificates can be found here:

FDA Certificate 2020

EC certificate valid until 26 May 2024

Certificate ISO 9001:2015 valid until 2023-09-25

Declaration of Conformity Sports & Medical

Declaration of Conformity Monark Medical Treadmill 2017-10-04

Free sales certificate valid until 2020-10-12

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