BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TransForm McCarthy Mitral Annuloplasty Ring

    Reg #: 1723241 · FEI: 1000517719 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    GENESEE BIOMEDICAL, INC.
    Registration Number
    1723241
    FEI Number
    1000517719
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    700 W Mississippi Ave Unit D5
    City
    DENVER
    State
    CO
    ZIP
    80223
    Country
    US

    Regulatory Submissions

    510(k) Number
    K232599

    Owner / Operator

    Firm Name
    GENESEE BIOMEDICAL, INC.
    Operator Number
    9012312
    Address
    700 W Mississippi Ave, Unit D-5
    City
    Denver
    State
    CO
    Postal Code
    80223
    Country
    US
    Correspondent
    James Cross

    Products

    Device Name Product Code
    Sizer, Heart-Valve, Prosthesis DTI
    Ring, Annuloplasty KRH

    Proprietary Names

    TransForm McCarthy Mitral Annuloplasty Ring TransForm McCarthy Mitral Annuloplasty Ring Sizers

    Establishment Types

    Manufacture Medical Device