Medical devices – option 5

Number / Technical Specifications / Unit of Measure / Quantity 1. Self-expanding stent specifically for carotid arteries; 5 FR system; System length 135 cm; Guidewires – maximum diameter 0.014”, length 150-190; Continuous radial resistance; Low-profile stent delivery system; Ro markers; Repositionable when partially deployed; High flexibility in areas with irregular anatomy. - pieces - 50 Everywhere in the Specification, where a specific model, source, process, trademark, type, origin or manufacture is indicated, which would result in the favoring or elimination of certain persons or products, it shall be read and understood as "or equivalent". 1. The proposed medical devices must fully comply with the requirements of the Technical Specification, as well as the relevant technical requirements, according to the submitted certificates and other accompanying documents, proving this. 2. The proposed medical devices and the participants in the tender must be included in the List of medical devices by groups, which the NHIF pays for under hospital medical care, and the amount for which the NHIF pays for each group, compiled in accordance with Art. 13, para. 2, item 2, letter "a" of Ordinance No. 10 of 2009 on the conditions, procedure, mechanism and criteria for payment by the National Health Insurance Fund for medicinal products, medical devices and dietary foods for special medical purposes, contracting discounts and recovery of excess funds when applying a mechanism guaranteeing predictability and sustainability of the NHIF budget, in force as of the date of announcement of the open procedure. 3. The shelf life of the medical devices must be no less than 75 (seventy-five)% of the shelf life indicated by the manufacturer, at the time of delivery.; 4. The participant must submit catalogs, brochures, information sheets or equivalent with the proposed medical devices to their technical proposal, containing detailed information about them with a Bulgarian translation, from which all indicators and production characteristics are visible, proving beyond doubt the quality of the proposed device and its compliance with the technical specifications and equipment. In the catalog/brochure etc., the participant must also mark the nomenclature number, which must correspond to the nomenclature number from the Technical Specification to which it relates. ​​​​​​​