BEUDAMED
    FDA Registration Active 🇨🇳 China

    Blood Pressure Monitor

    Reg #: 3003980573 · FEI: 3003980573 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TRULY INSTRUMENT CO., LTD.
    Registration Number
    3003980573
    FEI Number
    3003980573
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    NORTH OF THE DONG CHONG ROAD, IND. AREA
    City
    SHANWEI SHI Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K014141

    Owner / Operator

    Firm Name
    TRULY INSTRUMENT CO., LTD.
    Operator Number
    9055362
    Address
    NORTH OF THE DONG CHONG ROAD, IND. AREA
    City
    SHANWEI SHI, GUANG DONG
    State
    CN-NOTA
    Postal Code
    516600
    Country
    CN

    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

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)