BEUDAMED
    FDA Registration Active 🇲🇽 Mexico

    Orbit GALAXY Detachable Coil System

    Reg #: 3008264254 · FEI: 3008264254 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Cerenovus, Inc.
    Registration Number
    3008264254
    FEI Number
    3008264254
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Calle Circuito Interior Norte #1820, Parque Industrial Salvarcar
    City
    Ciudad Juarez, Chihuahua Mexico
    Country
    MX

    Regulatory Submissions

    510(k) Number
    K093973

    Owner / Operator

    Firm Name
    Cerenovus, Inc.
    Operator Number
    9026915
    Address
    31 Technology Drive, --
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Kevin Leung

    US Agent

    Business Name
    Cerenovus, Inc.
    Contact Name
    Kevin Leung
    Address
    31 Technology Dr
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US
    Email
    [email protected]
    Phone
    562 5474067

    Products

    Device Name Product Code
    Device, Vascular, For Promoting Embolization KRD
    Device, Neurovascular Embolization HCG

    Proprietary Names

    Orbit GALAXY Detachable Coil System

    Establishment Types

    Manufacture Medical Device