BEUDAMED
    FDA Registration Active 🇺🇸 United States

    IMEX Scleral Buckling Device, Ophthalmic

    Reg #: 1218813 · FEI: 1218813 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MIRA, INC.
    Registration Number
    1218813
    FEI Number
    1218813
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    414 Quaker Hwy
    City
    UXBRIDGE
    State
    MA
    ZIP
    01569
    Country
    US

    Regulatory Submissions

    510(k) Number
    K950806

    Owner / Operator

    Firm Name
    MIRA, INC.
    Operator Number
    1218813
    Address
    414 QUAKER HIGHWAY, --
    City
    Uxbridge
    State
    MA
    Postal Code
    01569
    Country
    US
    Correspondent
    Charles A Schepens

    Products

    Device Name Product Code
    Implant, Orbital, Extra-Ocular HQX

    Proprietary Names

    IMEX Scleral Buckling Device, Ophthalmic

    Establishment Types

    Manufacture Medical Device