Manufacturer: Entronom Elektronik Bilg. İnş.Teks. Eğt. Tur. San. Ve Tic. Ltd .Şti.……….………………….. . İvedik Osb Mah. 1371 Sok No:29 Yenimahalle/Ankara/Türkiye Tel: +90.312.385 81 78 Document Code Revision No TD.02/ 1.2.1/ Rev:01/04.12.2022 EC DECLARATION OF CONFORMITY Medical Device Directive, 93/42 / EEC +2007/47/EC Product Name : Oxygen Concentrator Model Purpose of Usage : Vita Basic3, Vita Plus3, Vita Ultimate3, Vita Basic5, Vita Plus5, Vita Ultimate5 Vita Basic10, Vita plus10, Vita Ultimate10 : The Oxygen Concentrator is designed to provide purified oxygen to patients requiring oxygen therapy in hospital and at home. However, the Oxygen Concentrator is not suitable for use as life support. : 12873- Oxygen Concentrator Harmonized Standards Class / Rules (MDD 93/42/EEC) Conformity Assessment Notified Body Notified Body ID Notified Body Address Certificate Number First Release Date Expiry Date : TS EN ISO 13485:2016,TS_EN_ISO_80601_2_69, ISO 3744:2010, ISO 4135:2001, ISO 7396‐1:2007, IEC 60601‐1:2005+ Amendment 1:2012, IEC 60601‐1‐2:2007, IEC 60601‐ 1‐6:2010+Amendment 1:2013, IEC 60601‐1‐8:2006+Amendment 1:2012, IEC 60601‐1‐ 11:2010, IEC 62366:2007+Amendment 1:2014’ : IIa / Rules 11 : Excluding part 4 of Annex II : UDEM ULUSLAR ARASI BELGELENDİRME A.Ş. : 2292 : MUTLU KENT MAH. 2073 SOK. NO:10 ÇANKAYA-ANKARA : M.2021.106.14665 : 25.05.2021 : 27.05.2024 Declaration: «Entronom Elektronik Bilg. İnş. Teks. Eğt. Tur. San. Ve Tic. Ltd. Sti. » As above name, description, product model number, etc. The information states that the product is CE marked and meets the requirements of the Medical Devices Directive 93/42 / EEC + 2007/47 / EC (this directive permits the free movement and sale of the above-mentioned product in all European Union countries). All supporting documentation "Entronom Elektronik Bilg. İnş. Teks. Eğt. Tur. San. Ve Tic. Ltd. Sti” in the facilities of the company. This Compliance of all the above mentioned product model numbers of medical devices «Entronom Elektronik Bilg. İnş. Teks. Eğt. Tur. San. Ve Tic. Ltd. Sti. » and is included in the certified Quality System Documentation. Date, Place