BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    SmartDiabetes Automatic Blood Pressure Monitor

    Reg #: 3003657019 · FEI: 3003657019 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    TRULY INSTRUMENT LIMITED
    Registration Number
    3003657019
    FEI Number
    3003657019
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2ND FLOOR, 1-3 WING YIP ST.
    City
    KWAI CHUNG
    Country
    HK

    Regulatory Submissions

    510(k) Number
    K081852

    Owner / Operator

    Firm Name
    TRULY INSTRUMENT LIMITED
    Operator Number
    9054344
    Address
    2ND FLOOR, 1-3 WING YIP ST., --
    City
    KWAI CHUNG
    State
    HK-NOTA
    Postal Code
    --
    Country
    HK

    US Agent

    Business Name
    Truly (U.S.A.) Inc.
    Contact Name
    Max Wong
    Address
    2620 Concord Avenue, Suite 106
    City
    Alhambra
    State
    CA
    ZIP
    91803
    Country
    US
    Email
    [email protected]
    Phone
    626 2843033

    Products

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

    Proprietary Names

    SmartDiabetes Automatic Blood Pressure Monitor Truly Automatic Blood Pressure Monitor Infopia Automatic Blood Pressure Monitor PressurePlus Automatic Blood Pressure Monitor

    Establishment Types

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