Certificates
SPHERE LIFE has undergone a long journey of clinical research and medical equipment certification, and today we are ready to offer you certified products that comply with all international standards.
Certificate of Conformity
This Certificate certifies that the products REGENERATOR SF-01 and REGENERATOR SF-02, Class IIa, comply with the requirements of the Technical Regulation on Medical Devices approved by Resolution of the Cabinet of Ministers of Ukraine No. 753 dated October 2, 2013.
Registered in the Register of LLC “UCMSP” on June 9, 2023, No. UA.TR.098.0419-23.
ISO 13485:2018 Certificate
This Certificate certifies that the QUALITY MANAGEMENT SYSTEM related to the development and distribution of physiotherapy devices REGENERATOR SF-01 and REGENERATOR SF-02, Class IIa, complies with the requirements of DSTU ISO 13485:2018, IDT, ISO 13485:2016 IDT.
Registered in the Register of LLC “UCMSP” on June 9, 2023, No. UA.R8.098.0042-23.
SES Certificate
This Certificate certifies that the physiotherapy devices REGENERATOR SF-01 and REGENERATOR SF-02 are manufactured in accordance with TU.U 26.6-44064545-001:2021 “Physiotherapy Device ‘SF’. Technical Specifications.”
Registered in the Register of the State Service (DSUPBKhPZS) on December 6, 2021, No. 12.2-18-1 21149.
