Confirmation Statement:

CH-REP.me (TAS SAT AG) confirms that, as of the date indicated above, an active mandate exists with VDI Technologies s.r.o.. Under this mandate, CH-REP.me (TAS SAT AG) acts as their appointed Swiss Authorised Representative (CH-REP).

This appointment enables the manufacturer to meet the relevant requirements concerning authorised representation as stipulated by the Swiss:

• Medical Devices Ordinance (MepV - SR 812.213)

• Ordinance on In Vitro Diagnostic Medical Devices (IvDV - SR 812.219)

CH-REP.me (TAS SAT AG), in its capacity as CH-REP, performs the duties assigned to the Swiss Authorised Representative under these regulations and the mandate agreement, acting as the primary contact point for Swissmedic and facilitating compliance activities related to representation within Switzerland. The manufacturer's registration with Swissmedic (as indicated above) is a prerequisite step facilitated through this representation.

Important Disclaimer:

This confirmation pertains specifically to the formal appointment and registration of CH-REP.me (TAS SAT AG) acting as the Swiss Authorised Representative (CH-REP) on behalf of VDI Technologies s.r.o., and the manufacturer's registration as an economic operator with Swissmedic.

This confirmation does not constitute an official certification of product conformity (e.g., CE marking validation or Swiss conformity assessment) by Swissmedic or a Notified Body, nor does it confirm the registration or notification status of specific devices.

The manufacturer remains ultimately responsible for ensuring the overall conformity, safety, quality, and performance of their devices, including maintaining the necessary technical documentation, conducting post-market surveillance, fulfilling vigilance obligations, ensuring appropriate device registration/notification where required, and meeting all other applicable manufacturer requirements under Swiss law.

This confirmation is valid only as long as the contractual mandate between VDI Technologies s.r.o. and CH-REP.me (TAS SAT AG) remains active and both parties fulfill their respective regulatory duties.