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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 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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