BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    Menicon Z Irregular Cornea

    Reg #: 9614761 · FEI: 1000188353 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MENICON CO. LTD.
    Registration Number
    9614761
    FEI Number
    1000188353
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    21-19 AOI, 3-CHOME, NAKA-KU
    City
    NAGOYA Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K081443

    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
    Lens, Contact (Other Material) - Daily HQD

    Proprietary Names

    Menicon Z Irregular Cornea

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198