BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Kerato Analyzer

    Reg #: 9680854 · FEI: 1000494121 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    KONAN MEDICAL, INC.
    Registration Number
    9680854
    FEI Number
    1000494121
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    10-29 MIYANISHI-CHO
    City
    NISHINOMIYA Hyogo
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K040373

    Owner / Operator

    Firm Name
    KONAN MEDICAL, INC.
    Operator Number
    9011976
    Address
    10-29 MIYANISHI-CHO,, NISHINOMIYA
    City
    HYOGO
    State
    JP-28
    Postal Code
    662-0976
    Country
    JP

    US Agent

    Business Name
    Konan Medical USA, Inc.
    Contact Name
    Dale Sadlik
    Address
    15570 Laguna Canyon Road, Suite150
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    949 5762200

    Products

    Device Name Product Code
    Microscope, Specular NQE

    Proprietary Names

    Kerato Analyzer CellChek D

    Establishment Types

    Manufacture Medical Device