BEUDAMED
    FDA Registration Active 🇺🇸 United States

    MENICON AMERICA, INC.

    Reg #: 3003515967 · FEI: 3003515967 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    5

    Registration Details

    Registration Name
    MENICON AMERICA, INC.
    Registration Number
    3003515967
    FEI Number
    3003515967
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    76 Treble Cove Rd., Bldg. #3
    City
    North Billerica
    State
    MA
    ZIP
    01862
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173136

    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

    Products

    Device Name Product Code
    Products, Contact Lens Care, Rigid Gas Permeable MRC
    Lenses, Soft Contact, Daily Wear LPL
    Case, Contact Lens LRX
    Lens, Contact, (Disposable) MVN
    Accessories, Soft Lens Products LPN

    Proprietary Names

    Menicon Progent Protein Remover Menicon Unique pH Multi-Purpose Solution Miru 1month Menicon (1Month SiHy) Progent Large Diameter Contact Lens Case for Rigid Gas Permeable Lens Miru 1day UpSide (1 Day SiHy) LacriPure

    Establishment Types

    Repack or Relabel Medical Device