BEUDAMED
    FDA Registration Active 🇺🇸 United States

    KONAN MEDICAL USA, INC.

    Reg #: 3005955744 · FEI: 3005955744 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    3
    Classifications
    6

    Registration Details

    Registration Name
    KONAN MEDICAL USA, INC.
    Registration Number
    3005955744
    FEI Number
    3005955744
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    15770 Laguna Canyon Road, Suite 150
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K001117

    Owner / Operator

    Firm Name
    KONAN MEDICAL USA, INC.
    Operator Number
    10027489
    Address
    15770 LAGUNA CANYON ROAD, SUITE 150
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    DALE SADLIK

    Products

    Device Name Product Code
    Pupillograph HRI
    Electrode, Cutaneous GXY
    Stand, Instrument, Ophthalmic, Non-Powered HMG
    Stimulator, Photic, Evoked Response GWE
    Tester, Color Vision HIT
    Perimeter, Automatic, Ac-Powered HPT

    Proprietary Names

    EYEKINETIX M339 DME CARBON CL M379 DME CARBON R CHINREST EVOKEDx COLORDx CCT HD objectiveFIELD Analyzer

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility