3EC International a.s., Hranicna 18, 821 05 Bratislava, Slovak Republic EMS Handels Gesellschaft m.b.H. Jochingergasse 1, 2100 Korneuburg, Austria SRN No.: AT-MF-000002599 This EU Quality Management System Certificate issued in accordance with the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices as amended confirms, that quality management system of medical device: Electroencephalograph model: see Annex I Intended purpose: see Annex II MD class lla / rule 10 (detailed list is stated in the annex(es) if applicable) meets the requirements on quality management system according to the Chapter I and III of Annex IX of the Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices as amended. Conditions for or limitations to the validity of the certificate: N/A Validity of the certificate is conditional upon positive results of regular surveillance audits. Notified body No. 2265 has performed assessment of the quality management system of the abovementioned medical device and found that it meets the requirements stated above. The outcome of the assessment of the quality management system of the abovementioned medical device is stated in the MD Technical Documentation Assessment Report No. MDR455_2024 from 12.06.2024, MD Clinical Evaluation Report No. MDR455_2024 from 12.06.2024 and MD Audit Report No. MDR455_2024 from 12.06.2024. Information on all examinations and tests performed is stated in the abovementioned reports and is available on request. This EU Quality Management System Certificate applies only to the quality management system of the abovementioned medical device. The certificate validity is conditional upon fulfilment of relevant legal requirements by the manufacturer. Valid from: 19.06.2024 Valid until: 19.06.2029 First issue: 19.06.2024 Revision: 00 History: see Annex III ZpC International a.s. Kat&rfna Tomin Srdosov£, PhD. ©naflaro* cantn K AS ICO. a. s. Bratislava. KC23-00215

Jochingergasse 1, 2100 Korneuburg, Austria List of medical devices covered by the EU Quality Management System Certificate ajafina Tomin Sfrdosova, PhD. In Bratislava, Slovakia, 19.06.2024 Valid until 19.06.2029 ©TladiareA canin KASICO, a. s. Bratislava, KC23-00215

Jochingergasse 1, 2100 Korneuburg, Austria Intended purpose of medical devices covered by the EU Quality Management System Certificate: Intended to be used for the recording and analysis of electrical activity in the brain, for the monitoring of brain function and for the diagnosis of Neurological Disorders, Evaluation of Sleep Disorders, Seizure Detection and Monitoring as well as for the Assessment of Brain Function in Anaesthesia. iajafrina Tomin Srdosova, PhD. In Bratislava, Slovakia, 19.06.2024 Valid until 19.06.2029 ©Titian* ce~n KASICO. a s. Bralislava. KC23-00215

Jochingergasse 1, 2100 Korneuburg, Austria Certificate history ^OVAN^S-ina Tomin Srdosova, PhD. In Bratislava, Slovakia, 19.06.2024 Valid until 19.06.2029 ©TlaClarert oanln KASICO, a s Bratislava, KC23 00215