Documentation
Our equipment has a full package of permits.
Product quality is monitored at all stages of design, development and production and is certified to meet the requirements of ISO 13485-2017 quality standards.
NPK KURS provides comprehensive technical support and warranty and post-warranty maintenance of all our products throughout the entire life of the product.
The KURS-FN-01 neonatal phototherapy apparatus is manufactured in accordance with TU 9444-001-60700287-2009, GOST R 50444-92, GOST R 50267.0-92, GOST R IEC 60601-1-2-2014.
Depending on the degree of potential risk of use, the product belongs to class 2a according to GOST 31508-2012 (medical devices with an average degree of risk).
The product according to the consequences of failure belongs to class B according to GOST R 50444-92 and RD 50-707-91.
Registration Certificate No. ФСР 2009/05157 dated February 24, 2014, issued by the Federal Service for Supervision of Healthcare, Russia. Validity - not limited.
Declaration of conformity with the technical regulation of the customs union TR TS 020/2011 "Electromagnetic compatibility of technical equipment" EACC No. RU D-RU.AL16.V.72819 adopted on the basis of Test Report No. 08258-219-1-17 / BM of 04/27/2017 Testing laboratory of Innovative Solutions LLC. Validity from 04/26/2017 to 04/25/2022
Certificate of Conformity No. РОСС RU.АД36.Н00162 issued by the Certification Body for Medical Devices “MEDITEST”. Validity from 02/27/2019 to 05/16/2020
License for the production and maintenance of medical equipment No. FS-99-04-001579 dated 06/30/2014 issued by the Federal Service for Supervision of Healthcare, Russia. Validity - not limited.
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