EC CERTIFICATEProduction Quality AssuranceMedical Devices Directive 93/42/EEC Annex V Company Name : Enfronom Elektronik Bilg. ins. Teks. Egt. Tur. San. ve. Tic. Ltd. $fi. Company Address : (vedik Osb Mah. Agag !§leri San. Sit. 1371 Sok No:29 K:2/3 ivedik Yenimahalle 06378 ANKARA / TURKEY Related Directives and Annex : 93/42/EEC Medical Devices Directive - Annex V : Oxygen Concentrator - Class lla Modelles : VITA BASIC 3, VITA PLUS 3, VITA ULTIMATE 3 VITA BASIC 5, VITA PLUS 5, VITA ULTIMATE 5 VITA BASIC 10, VITA PLUS 10, VITA ULTIMATE 10 Certificate Number Report Number Initial Assessment Date Registration Date Revision Date /No Expiry Date UDEM hereby declares that the requirements of Annex V of the directive 93/42/EEC have been met for the listed products. The above named manufacturer has established and applies a quality assurance system!, which is subject to periodic surveillance audits, defined by Annex V. section 4 of the aforementioned directive. UOEM's responsibility for class I devices covered by the EC sertificate is Smiled to manufacturing issues related to safeguarding and maintaining sterile conditions, if the dev.ce is sterile; and manufacturing issues related to product's conformity with metrological requirements, if it has measurement function. This certificate remains as the property of UDEM International Certification Auditing Training Centre Industry and Trade Inc. Co. to whom it must be returned upon request. The above named company and UDEM must keep a copy of this certificate for 5 years from the registration of the certificate. Usage of the CE mark is under the responsibifity of the manufacturer with the completion of EC Declaration of Conformity. The above mentioned company must notify oil changes related with the approved product to UDEM. If UDEM wilt not renew the expiry date of this certificate in question, the mentioned company should stop placing the product on the market. The vafldity of the certificate can be checked through vsnvw.udem.com. tr. Address: Mutlukent Mahallesi 2073 Sokak (Eski 93 Sokak) No:10 Qankaya - Ankara - TURKEY Phone: +90 0312 443 03 90 Fax: +90 0312 443 03 76 E-mail: [email protected] www.udem.com.fr