Add value. Inspire trust. TUV SUD Product Service GmbH Ridlerstr. 65 80339 Munich Germany Your reference/letter of Our reference/name Tel. extension/Email Fax extension TUV SUD Product Service GmbH Confirmation Letter CL 119354 0001 Rev. 00 Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 (in the following referenced as MDR) as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. With this letter TUV SUD Product Service GmbH, designated under MDR and identified by the number 0123 on NANDO, confirms that we have received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the above stated manufacturer with the following SRN Number: The devices covered by the formal application and the written agreement mentioned above are identified in the Tables below. Table 1 identifies the devices for which an MDR application has been received, written agreement concluded and for which TUV SUD Product Service GmbH is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive. Table 2 identifies the devices for which an MDR application has been received and a written agreement concluded, but TUV SUD Product Service GmbH has not yet taken the responsibility for appropriate surveillance of the corresponding devices under the applicable Directive. Registered Office: Munich Trade Register Munich HRB 85 742 UniCredit Bank AG BIC HYVEDEMMXXX I BAN DE13 7002 0270 0048 8522 11 VAT ID No. DE129484267 Information pursuant to § 2 [1] DL-InfoV (Germany) attuvsud.com/imprint Supervisory Board: Holger Lindner (Chairman) Walter Reithmaier (CEO) Patrick van Welij TUV SUD Product Service GmbH Certification body for medical Products Ridlerstr. 65 80339 Munich Germany

If devices covered by certificates issued under Directive 90/385/EEC (AIMDD) or Directive 93/42/EEC (MDD) that expired after 26 May 2021 and before 20 March 2023, without having been withdrawn, this letter also confirms that: the manufacturer signed the written agreement under MDR by the date of MDD/AIMDD certificate expiry; or provided evidence that a competent authority of a Member State had granted a derogation or exemption from the applicable conformity assessment procedure in accordance with Article 59(1) of MDR or Article 97(1) of the MDR respectively. The transition timelines in accordance...

Table 1: Devices covered by this letter and for which TUV SUD Product Service GmbH is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive: N/A Table 2: Devices covered by this letter and for which TUV SUD Product Service GmbH is NOT responsible for appropriate surveillance of the corresponding devices under the applicable Directive: Device name or Basic I'DI-DI (under MDR application) □ Identification of the corresponding device under MDD AIMDD Individual Article number: □ Identification of die corresponding device under MDD/AIMDD MDR Device...

Device name or Basic UDI-DI (under MDR application) MDR Device classification If the MDR device is a substitute (as proposed by the manu- device, identification of the cor-facturer and verified during responding MDD/AIMDD derice application review) □ Class I devices in sterile Individual Article number: condition □ Class I devices with meas uring function □ Class in implantable custom-made-device □ Class I reusable surgical instruments □ Class lib implantable (non-exempted) □ Class lib / Class Db implantable (exempted) □ Class I devices in sterile condition □ Class I devices with measuring function...

Device name or Basic UDI-DI (under MDR application) MDR Device classification (as proposed by the manufacturer and verified during application review) □ Class lib implantable (non-exempted) □ Class lib / Class Hb implantable (exempted) □ Class I devices in sterile condition □ Class I devices with measuring function □ Class III implantable custom-made-device □ Class I reusable surgical iustiuments If the MDR device is a substitute device, identification of the corresponding MDD/AIMDD device □ Identification of die correspoud-ing device under MDD/AIMDD Individual Article number: □ Class lib implantable...

Device name or Basic UDI-DI (under MDR application) MDR Device classification (as proposed by the manufacturer and verified during application review) □ Class I reusable surgical instruments derice, identification of the corresponding MDD/AIMDD derice El Certification as follows: Certificate #EG19/19020; NB# 1639 □ Class lib implantable (non-exempted) □ Class lib / Class Db implantable (exempted) El Class I devices in sterile condition □ Class I devices with measuring function □ Class in implantable custom-made-derice □ Class I reusable surgical □ Identification of tire corresponding device under...