BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ASTRA

    Reg #: 3005919188 · FEI: 3005919188 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CANDELIS, INC.
    Registration Number
    3005919188
    FEI Number
    3005919188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4701 Von Karman Avenue, Suite 200
    City
    Newport Beach
    State
    CA
    ZIP
    92660
    Country
    US

    Regulatory Submissions

    510(k) Number
    K111694

    Owner / Operator

    Firm Name
    Candelis, Inc.
    Operator Number
    9092139
    Address
    4701 Von Karman Avenue, Suite 200, --
    City
    Newport Beach
    State
    CA
    Postal Code
    92660
    Country
    US
    Correspondent
    Larry Collie

    Products

    Device Name Product Code
    System, Image Processing, Radiological LLZ

    Proprietary Names

    ASTRA

    Establishment Types

    Manufacture Medical Device