Documentation
The KURS-FN-01 neonatal phototherapy device is included in the Unified Register of the Radioelectronic Industry of the Russian Federation.
Registration number 10904637, dated August 25, 2026.
Our equipment has a full package of permits.
Product quality is monitored at all stages of design, development, and production and is certified for compliance with the ISO 13485-2017 (ISO 13485:2016) quality standard for medical device manufacturers. This certification is valid from March 4, 2024, to March 4, 2027.
KURS Scientific and Production Corporation provides comprehensive technical support, warranty, and post-warranty service for all our products throughout their entire service life.
The KURS-FN-01 neonatal phototherapy device is manufactured in accordance with TU 9444-001-60700287-2009.
Depending on the degree of potential risk, the product is classified as Class 2a according to GOST 31508-2012 (medical devices with a medium risk).Based on the consequences of failure, the product is classified as Class B according to GOST R 50444-2020.
Registration Certificate No. FSR 2009/05157 dated May 30, 2023, issued by the Federal Service for Surveillance in Healthcare. Valid for an unlimited period.
Declaration of Conformity with the Technical Regulations of the Customs Union CU TR 004/2011 "On the Safety of Low-Voltage Equipment" and CU TR 020/2011 "Electromagnetic Compatibility of Technical Equipment" EACC No. RU D-RU PA03.B.07748/22, adopted based on Test Report No. 18949X dated April 14, 2022. Testing Laboratory "Express-Test." Valid from April 15, 2022, to April 13, 2027.
Certificate of Conformity No. ROSS RU.ML10.N00523 issued by Product Certification Authority Erri-test LLC. Valid from March 26, 2025, to March 25, 2028.
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