• Certificate for neurostimulator «NeySi-3M» for Ukraine

— Certificate of Conformity: Series BB No. 094821. The device for electrical stimulation, neurostimulator Neysi-3M, is certified by the State Committee of Ukraine for technical regulation and consumer.
— Clinical trial protocol. Clinical trials of the implantable neurostimulator NeCi-3M have been completed. Technical conditions TU U 33.1-30972877-001: 2008.
— Technical conditions for the implantable neurostimulator NeySi-3M were registered. Certificate of state registration No. 7439/2008.
— The certificate of state registration of the Neysi-3M was received. Neysi-3M is included in the State Register of Medical Equipment. The use of Neisi-3M in medical practice is allowed.

The act of qualifying tests «NeySi-3M»

National Medical Academy of Graduate Education. Department of Neurosurgery. Report from 11.12.07

Protocol of preclinical tests on the Device for electrical stimulation «NeySi-3M» as part of «Block generator with transmitting antenna» and «Reception antenna with electrodes» (according to TU U 33.1-30972877-001:2006).

The act of acceptance technical tests

Protocol of tests for toxicity of the Receiving antenna with electrodes, which is an integral part of the Device for Electrical Stimulation «NeySi-3M» Conclusion of the State Sanitary and Epidemiological Examination on Technical Conditions «Device for Electrical Stimulation «NeySi-3M»» TU U 33.1-30972877-001:2006

Conclusion of the State Sanitary and Epidemiological Examination on the Device for Electrical Stimulation «NeySi-3M» as part of «Block generator with transmitting antenna» and «Reception antenna with electrodes» (according to TU U 33.1-30972877-001:2006).

Instructions for the use of the NeySi-3M medical product

Treatment of patients with shoulder plexus paralysis by stimulating spinal cord pillars with implanted electrodes

Information about medical and technical innovation, which is recommended for implementation

Extract from the minutes of the meeting of the Scientific Council of the Institute of Neurosurgery. Ui. A.P.Romadanov on the results of clinical use of implantable neurostimulists

Institute of Neurosurgery. Ui. A. P. Romodanova AMN Ukraine. Department of Restorative Neurosurgery. Installation of NeySi-3M neurostimulator electrodes on the damaged spinal cord. Photos.

The use of the neurostimulator NeySi-3M in the treatment of the ischemic contracture Volkmann. Report

Certificate of conformity of the project for the Neysi-3M neurostimulation system with the requirements of the Technical Regulations regarding active medical devices that are implanted, approved by the Resolution of the Cabinet of Ministers of Ukraine dated 02.10.2013 No. 755. This technical regulation is based on Directive 90/385 / EEC relating to active implantable medical devices (Directive AIMDD).

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Permitting documents for the NeySi-3M neurostimulation system