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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 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
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Russia Medical Device Registration
Issued and recorded by the Federal Service of Welfare, Russia
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