Certification

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  • FDA 510(k) Clearance Letter - K212857

    FDA 510(k) Clearance Letter - K212857

  • ISO 13485:2016 Certificate

    ISO 13485:2016 Certificate

  • EU MDR Certificate - Regulation (EU) 2017/745

    EU MDR Certificate - Regulation (EU) 2017/745

  • FDA 510(k) Indications for Use - K212857

    FDA 510(k) Indications for Use - K212857

  • FDA Facility Registration 2026

    FDA Facility Registration 2026

  • RoHS Verification

    RoHS Verification

  • RoHS 2.0 Test Report

    RoHS 2.0 Test Report

  • First Class Medical Device Production Filing Certificate

    First Class Medical Device Production Filing Certificate