declation_of_confirmity

Product catalog summary

EC Declaration of Conformity Overview

Manufacturer Information: Entronom Elektronik Bilg. İnş. Teks. Eğt. Tur. San. Ve Tic. Ltd. Şti., located in Yenimahalle, Ankara, Turkey. Contact: +90.312.385 81 78.

Document Details: Document Code: TD.02/1.2.1, Revision No: 01, Date: 04.12.2022.

Product Information: The document pertains to Oxygen Concentrators under the brand names Vita Basic, Vita Plus, and Vita Ultimate, with models ranging from 3 to 10. These devices are intended to provide purified oxygen for patients requiring oxygen therapy, suitable for both hospital and home use, but not for life support.

Standards and Compliance: The product complies with the Medical Device Directive 93/42/EEC + 2007/47/EC and is CE marked. It adheres to harmonized standards including TS EN ISO 13485:2016, IEC 60601 series, and others relevant to medical devices.

Classification: Classified as Class IIa under MDD 93/42/EEC, Rule 11.

Conformity Assessment: Conducted by UDEM ULUSLAR ARASI BELGELENDİRME A.Ş., Notified Body ID: 2292, with Certificate Number: M.2021.106.14665. The first release date was 25.05.2021, with an expiry date of 27.05.2024.

Declaration: The declaration confirms that the product meets the necessary requirements for free movement and sale within the EU. All supporting documentation is maintained at the company's facilities.

Signatory: The declaration is signed by the General Manager, Gülsüm Hakimoğlu, on 01.12.2020 in Ankara.

Catalog excerpts

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

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Catalog excerpts

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