Certificates

Certificates

Certificates

KGMP

Korean Good Manufacturing Practice
(Medical device manufacturing & quality control standard conformity certificate)
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ISO13485:2016

Acquired the latest ISO Certification.
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CE MDD

Certified for compliance with EU medical device directives.
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FDA 510(k)

Obtained Class  II approval from the US FDA
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Certificate of R&D Department

Approved by the Korea Industrial Technology Association as a R&D department.
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INNO-BIZ

Certified as technologically innovative SME by the MSS
.
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