BEUDAMED
    FDA Registration Active 🇭🇰 Hong Kong

    Blood Pressure Monitor

    Reg #: 3003657019 · FEI: 3003657019 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    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
    K014141

    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

    Blood Pressure Monitor

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility