Confirmation Statement:

CH-REP.me (TAS SAT AG) confirms that, as of the date indicated above, an active mandate exists with GOLMED GmbH. Under this mandate, CH-REP.me (TAS SAT AG) acts as an appointed Swiss Importer for devices placed on the Swiss market by GOLMED GmbH.

This appointment enables the distributor and facilitates the fulfillment of relevant requirements concerning the importation of devices 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 Swiss Importer, performs the duties assigned to the Importer under these regulations and the mandate agreement. This includes, but is not limited to, verifying certain aspects of device compliance before importation, ensuring appropriate storage and transport conditions (where applicable under the mandate), cooperating with competent authorities, and maintaining required records. The registration of both economic operators (manufacturer and importer) with Swissmedic is a prerequisite for these activities.

Important Disclaimer:

This confirmation pertains specifically to the formal appointment and registration of CH-REP.me (TAS SAT AG) acting as the Swiss Importer on behalf of GOLMED GmbH, and the registration of both parties as economic operators 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, appointing a Swiss Authorised Representative (CH-REP), 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 GOLMED GmbH and CH-REP.me (TAS SAT AG) remains active and both parties fulfill their respective regulatory duties.