NejSi-3M

Regulatory documents and certificates for the NejSi-3M implantable neurostimulator

• Certificate for the NejSi-3M neurostimulator for Ukraine
  
  • Certificate of conformity: series ВВ No. 094821. Electrical stimulation device, neurostimulator NejSi-3M, certified by the State Committee of Ukraine for Technical Regulation and Consumer Policy.
  • Clinical test report. Clinical trials of the implantable neurostimulator have been completed NejSi-3M.
  • Technical specification ТУ У 33.1-30972877-001:2008. The technical specification for the implantable neurostimulator has been registered NejSi-3M.
  • State registration certificate No. 7439/2008. The state registration certificate for the NejSi-3M has been issued. The NejSi-3M is entered in the State Register of Medical Equipment and approved for use in medical practice.

Qualification test report for the NejSi-3M

National Medical Academy of Postgraduate Education. Department of Neurosurgery. Report of 11.12.07

Preclinical test report for the NejSi-3M electrical stimulation device, comprising the "generator unit with transmitting antenna" and the "receiving antenna with electrodes" (per ТУ У 33.1-30972877-001:2006).

Acceptance test report

Toxicity test report for the receiving antenna with electrodes, a component of the NejSi-3M electrical stimulation device

Conclusion of the State Sanitary and Epidemiological Assessment for the technical specification "NejSi-3M electrical stimulation device", ТУ У 33.1-30972877-001:2006

Conclusion of the State Sanitary and Epidemiological Assessment for the NejSi-3M electrical stimulation device, comprising the "generator unit with transmitting antenna" and the "receiving antenna with electrodes" (per ТУ У 33.1-30972877-001:2006).