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or a fault in the fit, please report to your
specialist medical retailer directly. Only
serious incidents which could lead to a
significant deterioration in health or to
death are to be reported to the
manufacturer or the relevant authorities
in the EU member state. The criteria for
serious incidents are defined in Section
2, No. 65 of the Regulation (EU) 2017/745
(MDR). The traceability of this product is
assured via a UDI code
.