Certificates
Declaration of Conformity:
Korean Food and Drug Administration:
Taiwan Ministry of Health and Welfare:
Free Sale Certificate:
FDA Premarket Submission 510(k) K211248 registration:
FDA Premarket Submission 510(k) K163121 registration:
FDA Premarket Submission 510(k) K161968 registration:
FDA Premarket Submission 510(k) K102253 registration:
FDA Premarket Submission 510(k) K113184 registration:
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Quality Management System Certificate EN-ISO 13485:2016…
Full size document see here (PDF)