Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Üniversiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey 29/09/2023 Notified Body Confirmation Letter Reference: EU2023-607/698006 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: Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Üniversiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 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]

06800 Turkey TR-MF-000014932 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 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...

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: Confirmation Letter Revision History Date 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]

EC Certificate - Production Quality Assurance Directive 93/42/EEC on Medical Devices, Annex V Supplementary Information to CE 77029 Issued To: No. Issued To: Kardinero Medikal Sistemler Sanayi ve CE 77029 Ticaret Anonim Sirketi Kardinero Medikal Sistemler Sanayi ve Üniversiteler Mah. Ihsan Dogramaci Bulv. No. 29 Ticaret Anonim Sirketi ODTU Teknokent Gumus Blok BK-7/B Cankaya Mah. Ihsan Dogramaci Bulv. No. 29 Üniversiteler Ankara ODTU Teknokent Gumus Blok BK-7/B 06800 Cankaya Turkey Ankara The manufacture of Class IIa PC based ECG systems and ECG stress test systems with treadmills on the basis...

Ticaret Anonim Sirketi Universiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey First Issued: 2003-11-12 Date: 2019-02-27 Expiry Date: 2023-11-11 Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued...

EC Certificate - Production Quality Assurance Directive 93/42/EEC on Medical Devices, Annex V Recognised as being involved in services relating to the product covered by: Issued To: Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Universiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey ...making excellence a habit!" Information and Contact: BSI, Say Building, John M. Keynesplein 9, 1066 EP Amsterdam, The Netherlands Tel: + 31 20 346 0780 BSI Group The Netherlands B.V. registered in The Netherlands under 33264284. A member of BSI...

EC Certificate - Production Quality Assurance Certificate History Certificate No: Date: Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Universiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless...

Issued To: Kardinero Medikal Sistemler Sanayi ve Ticaret Anonim Sirketi Universiteler Mah. Ihsan Dogramaci Bulv. No. 29 ODTU Teknokent Gumus Blok BK-7/B Cankaya Ankara 06800 Turkey Validity of this certificate is conditional on the quality system being maintained to the requirements of the Directive as demonstrated through the required surveillance activities of the Notified Body. This approval excludes all products designed and/or manufactured by a third party on behalf of the company named on this certificate, unless specifically agreed with BSI. This certificate was issued electronically and...