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Regulation and Certification

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




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