Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 USA 6 February 2024 Notified Body Confirmation Letter Reference: EU2023-607/651169 To whom it may concern, 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 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices This letter confirms that, BSI Group The Netherlands B.V., a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number 2797 on NANDO, has 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 following manufacturer: Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 USA SRN Number (if available): US-MF-000002324 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 the NB is also responsible for appropriate surveillance of the BSI Group The Netherlands B.V. Say Building John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Validity of this letter may be verified by writing to [email protected]

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 the NB has not yet taken the responsibility for appropriate surveillance of the corresponding devices under the applicable Directive. In the case of 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(AIMDD) or Directive 93/42/EEC (MDD) that expired after 26 May 2021 and before 20 March 2023, without having been withdrawn, this letter also confirms that the manufacturer signed the written agreement under MDR by...

Table 1: Devices covered by this letter and for which the NB is also responsible for appropriate surveillance of the corresponding devices under the applicable Directive: BSI Group The Netherlands B.V. Say Building John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands GOALS Validity of this letter may be verified by writing to [email protected]

Device name or Basic UDI-DI (under MDR application) BSI Group The Netherlands B.V. Say Building John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands GOALS Validity of this letter may be verified by writing to [email protected]

Device name or Basic UDI-DI (under MDR application) BSI Group The Netherlands B.V. Say Building John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands GOALS Validity of this letter may be verified by writing to [email protected]

Device name or Basic UDI-DI (under MDR application) Table 2: Devices covered by this letter and for which the NB is NOT responsible for appropriate surveillance of the corresponding devices under the applicable Directive: BSI Group The Netherlands B.V. Say Building John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands GOALS Date Validity of this letter may be verified by writing to [email protected]