Certificates

Certificates

Certificates

KGMP

Korean Good Manufacturing Practice
(Medical device manufacturing & quality control standard conformity certificate)
.

ISO13485:2016

Acquired the latest ISO Certification.
.
.
.

CE MDD

Certified for compliance with EU medical device directives.
.
.

FDA 510(k)

Obtained Class  II approval from the US FDA
.
.

Certificate of Corporate Research Institute

APPROVED by the Korea Industrial Technology Association as a Corporate Reserch Institue.

INNO-BIZ

Certified as technologically innovative SME by the MSS
.
.

Russia Medical Device Registration

Issued and recorded by the Federal Service of Welfare, Russia
.