BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MeniSept

    Reg #: 3003062331 · FEI: 3003062331 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Menicon Co., Ltd., R&D Center
    Registration Number
    3003062331
    FEI Number
    3003062331
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5-1-10, Takamoridai
    City
    Kasugai Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K191872

    Owner / Operator

    Firm Name
    MENICON CO. LTD.
    Operator Number
    9001029
    Address
    21-19 AOI, 3-CHOME, NAKA-KU, --
    City
    NAGOYA
    State
    Aichi
    Postal Code
    460-0006
    Country
    JP
    Correspondent
    Zhu Jiang

    US Agent

    Business Name
    MENICON AMERICA, INC.
    Contact Name
    Alberty Recio
    Address
    76 TREBLE COVE RD BLDG #3
    City
    N Billerica
    State
    MA
    ZIP
    01862
    Country
    US
    Email
    [email protected]
    Phone
    781 6092042

    Products

    Device Name Product Code
    Products, Contact Lens Care, Rigid Gas Permeable MRC
    Accessories, Soft Lens Products LPN

    Proprietary Names

    MeniSept

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility