Certificates
Declaration of Conformity:
Korean Food and Drug Administration:
Taiwan Ministry of Health and Welfare:
Free Sale Certificate:
Korean Food and Drug Administration:
Taiwan Ministry of Health and Welfare:
Free Sale Certificate:
- Free Sale Certificate (SmartUs, MicrUs, ArtUs, Echo Wave II)
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:
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:
A Quality Audit demonstrated compliance of the Quality Management System with EN ISO 13485:2016…
Full size document see here (PDF)
Full size document see here (PDF)
An Audit demonstrated compliance of the Quality Management System with Annex II of the Council Directive 93/42/EEC concerning Medical Devices...
Full size document see here (PDF)
Full size document see here (PDF)
Information on the Notify Body brand transition and change of legal entity name.
Full size document see here (PDF)
Full size document see here (PDF)
