Regulation and Certification | JÓLI360 | E.S.I Novel

Regulation and Certification

JÓLI360™ received the following safety regulation certifications:

European community (comply with CE) safety regulation such as:

 

Ó  IEC60601-1 Medical device Safety series

Ó  IEC60601-2-10 Medical electrical equipment 

Ó IEC60825 Laser safety and classification (1c)

Ó HIPPA & GDPR compliance

Ó K178390 compliance

Ó ISO13485

Ó Medical Device department Israel Ministry of Health certification

Ó E.A.R Certificate 

Ó Documentation review certificate ESI Novel