Certificates
The SPHERE LIFE company has gone a long way through clinical research and certification of medical equipment, and today we are ready to offer you certified products that meet all international standards.
.jpg)
Certificate of conformity
This certificate certifies that REGENERATOR SF-01 and REGENERATOR SF-02 Class IIa products meet the requirements of the Technical Regulations for Medical Devices, approved by Resolution No. 753 of the Cabinet of Ministers of Ukraine dated October 2, 2013. Registered in the Register of LLC "UCMSP" LLC on June 9, 2023, No. UA.TR.098.0419-23
ISO 13485:2018 certificate
This certificate certifies that the QUALITY MANAGEMENT SYSTEM for the development, manufacture, maintenance and distribution of devices for physiotherapy REGENERATOR SF-01, REGENERATOR SF-02 meets the requirements of DSTU ISO 13485:2018, IDT, ISO 13485:2016 IDT. Registered in the Register of LLC "UCMSP" LLC on June 9, 2023, No. UA.Я8.0042-23
Certificate of the Sanitary and Epidemiological Service
This certificate certifies that the device for physiotherapy REGENERATOR SF-01 and REGENERATOR SF-02 is manufactured in accordance with TU.U 26.6-44064545-001:2021 "Device for physiotherapy "SF". Technological conditions". Registered in the Register of DSUPBKHPZS on 06.12.2021 No. 12.2-18-1/21149
