29 April 2021, Istanbul, Turkey EC CertificateFull Quality Assurance System according to Medical Devices Directive 93/42/EEC Annex-ll Section 3 Certificate Number: 1984-MDD-18-524 We hereby declare that an examination of the under mentioned full quality assurance system has been carried out following the requirements of the national legislation to which the undersigned is subjected, transposing annex II (with the exemption of section 4) of the Directive 93/42/EEC on medical devices. We certify that the full quality assurance system conforms with the relevant provisions of the aforementioned directive. ikitelli OSB Mahallesi 17. Cadde No:17 Ba§ak§ehir, istanbul, Turkey Product: Sterile Infusion Therapy Devices Models: Needle-Free IV Connectors, Extension Lines, Filter Sets, IV Set Accessories Product: Disinfecting Cap Models: C100, C200 The certificate is valid till expiration date, subject to successful completion of periodical surveillance audits. Please contact Kiwa for details. Report Number: Date of first issue: Date of last issue: Revision Number: Expiry Date: Kiwa Belgelendirme Hizmetleri A.$. is Notified Body under Council Directive 93/42/EEC concerning medical devices with identification number: 1984 Muhte§em Gokhan Yucel Head of Notified Body Kiwa Belgelendirme Hizmetleri A.§. iTOSB 9. Cad. No:15 Tepedren, Tuzla, Istanbul. Turkey Tel.: +90 216 593 25 75 , Fax: +90 216 593 25 74 Web: www.kiwa.com.tr, e-mail: [email protected]