BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Arm Blood Pressure Monitor

    Reg #: 3004835896 · FEI: 3004835896 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    STAR ELITE
    Registration Number
    3004835896
    FEI Number
    3004835896
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1175 Place du Frere-Andre
    City
    Montreal Quebec
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K120058

    Owner / Operator

    Firm Name
    Star Elite Inc.
    Operator Number
    10081950
    Address
    1175 Place du Frere-Andre
    City
    Montreal
    State
    Quebec
    Postal Code
    H3B 3X9
    Country
    CA
    Correspondent
    Dimitri Paraskevopoulos

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Arm Blood Pressure Monitor

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device