BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JenaValve

    Reg #: 3012148004 · FEI: 3012148004 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    JENAVALVE TECHNOLOGY, INC.
    Registration Number
    3012148004
    FEI Number
    3012148004
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    4 Cromwell
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Owner / Operator

    Firm Name
    JenaValve Technology, Inc.
    Operator Number
    10051384
    Address
    4 Cromwell
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Jane Metcalf

    Products

    Device Name Product Code
    Aortic Valve, Prosthesis, Percutaneously Delivered NPT

    Proprietary Names

    JenaValve

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device