EU QUALITY ASSURANCE CERTIFICATE (EU) 2017/745 Medical Device Regulation Annex XI Part A Certificate Number: MDR.2292-2025/0008 Manufacturer Name : Mediteks Sağlık Hizmetleri Tıbbi Malz. Teks. Ürün. San. ve Dış Tic. A.Ş. Manufacturer Address : Head Office Address: Maslak Polaris Plaza Maslak Mah. Ahi Evran Cad. No:21, Kat 6, Office No:33, 34398 Sarıyer İSTANBUL / TÜRKİYE Manufacturing Address: Organize San. Bölgesi 4. Cad. No:5 Süloğlu EDİRNE / TÜRKİYE Single Registration Number-SRN Authorized Representative Name (If any) Authorized Representative Address Device/Device Group Name : - Sterile or Non-Sterile, With or Without X-Ray Composite Abdominal Compress - Sterile or Non-Sterile, With or Without X-Ray Gas Compress - Sterile or Non-Sterile, With or Without X-Ray Abdominal Compress - Sterile or Non-Sterile, With or Without X-Ray Cotton Pad - Sterile or Non-Sterile, With or Without X-Ray Gauze - Sterile Gauze Bandage *Detailed information is in the attached device list. Based on the conformity assessment of the quality management system of the above-mentioned manufacturer according to Annex XI Part A of (EU) 2017/745 Medical Device Regulation, UDEM A.Ş. declares that the relevant requirements are met for the products listed in this certificate. The manufacturer has established, documented and implemented a quality management system that is subject to periodic surveillance. assessments by UDEM A.Ş. in accordance with Annex XI Part A Section 7 of the related regulation All relevant reports starting with the number UDEM.0026 of the customer organization referred to below summarize the outcome of the assessments/reviews and refer to the relevant common specifications, if any, harmonized standards and test reports. Upon request, these reports are available in UDEM A.Ş. records in accordance with Section 10 of Chapter II of Annex XII of the MDR. For Class III and Class IIb devices covered by this certificate, an EU Type Examination Certificate is required before being placed on the market in accordance with Annex X of (EU) 2017/745 Medical Device Regulation. Customer Number Issue Date Revision Date/No Validity Date Previous Certificate(s) No., if any : Not Applicable. General Manager Stamp - Signature UDEM A.Ş. is a Notified Body under the (EU) 2017/745 Medical Device Regulation. Notified Body No: 2292 Mutlukent Mah. 2073. Sok. (Eski 93 Sokak) No:10 Ümitköy /ANKARA 0 312 443 03 90 [email protected] www.udem.com

EU QUALITY ASSURANCE CERTIFICATE (EU) 2017/745 Medical Device Regulation Annex XI Part A Certificate Number: MDR.2292-2025/0008 ANNEX: DEVICE LIST WITHIN THE SCOPE OF THE CERTIFICATE DEVICE PRODUCT/DEVICE GROUP CERTIFICATE HISTORY UDEM A.§. is a Notified Body under the (EU) 2017/745 Medical Device Regulation. Notified Body No: 2292 Mutlukent Mah. 2073. Sok. (Eski 93 Sokak) No: 10 Urnitkoy/ANKARA 0 312 443 03 90 [email protected] www.udem.com.tr