Permits and certificates

• Certificate for the neurostimulator "NeySi-3M" for Russia. 
  • Application to the certificate for the neurostimulator NEIS-3M
  • Certified under the order of Roszdravnadzor No.3664-Pr/11 of June 24, 2011, allowed for import, sale and use in the Russian Federation.
  • The official representative of THE EL NPP, which supplies Neisi-3M in the Russian Federation, is Medical Systems LLC.
    Contact information:
    455091, Chelyabinsk, Street Timiryazeva, d.24,
    Phones: 7-351-266-76-32, 7-909-081-73-61
    e-mail: info@m-sy.ru

 

• Certificate for neurostimulator "NeySi-3M" for Ukraine
  • Certificate of Compliance: SERIES V 094821. The device for electrical stimulation, the neurostimulator NESI-3M, is certified by the State Committee of Ukraine on Technical Regulation and Consumer.
  • Clinical trial protocol. The clinical tests of the neurostimulator implanted NEIsi-3M have been completed.
  • Technical conditions of TU U 33.1-30972877-001:2008. Technical conditions have been registered for the neurostimulator implanted neisi-3M.
  • Certificate of State Registration No. 7439/2008. The certificate of state registration of NESI-3M has been received. NeISi-3M is listed in the State Register of Medical Technology. The use of NESI-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 "Neisi-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 NaISi-3M electrical stimulation device

Conclusion of the State Sanitary and Epidemiological Examination on Technical Conditions "Naisi-3M Electrical Stimulation Device" 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).