BEUDAMED
    FDA Registration Active 🇯🇵 Japan

    MENICON CO. LTD.

    Reg #: 9614761 · FEI: 1000188353 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    MENICON CO. LTD.
    Registration Number
    9614761
    FEI Number
    1000188353
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    21-19 AOI, 3-CHOME, NAKA-KU
    City
    NAGOYA Aichi
    Country
    JP

    Regulatory Submissions

    510(k) Number
    K102895
    PMA Number
    P990018

    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, Orthokeratology, Overnight NUU
    Lens, Contact (Rigid Gas Permeable), Extended Wear MWL
    Lenses, Soft Contact, Daily Wear LPL
    Accessories, Soft Lens Products LPN
    Products, Contact Lens Care, Rigid Gas Permeable MRC
    Lens, Contact (Other Material) - Daily HQD
    Case, Contact Lens LRX
    Lens, Contact, (Disposable) MVN

    Proprietary Names

    MENICON Z RIGID GAS PERMEABLE CONTACT LENS Miru 1day Menicon Flat Pack Toric Miru 1day Menicon Flat Pack LacriPure Menicon Z Large Diameter MeniSept MENICON SP VIAL Menicon Z DW Menicon Unique pH Multi-Purpose Solution Miru 1month Menicon (1Month SiHy) Menicon Progent Protein Remover Menicon Nect Contact Lens Case Menicon Z Irregular Cornea Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens Miru 1day UpSide (1 Day SiHy)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198