BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    My-BP BP Management Application Software

    Reg #: 3006551178 · FEI: 3006551178 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    HEALTHSTATS INTERNATIONAL PTE. LTD.
    Registration Number
    3006551178
    FEI Number
    3006551178
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    82 Playfair Road, #07-02 D' Lithium
    City
    SINGAPORE Central Singapore
    Country
    SG

    Regulatory Submissions

    510(k) Number
    K131788

    Owner / Operator

    Firm Name
    HEALTHSTATS INTERNATIONAL PTE. LTD.
    Operator Number
    9082868
    Address
    82 Playfair Road, #07-02 D' Lithium
    City
    SINGAPORE
    State
    SG-NOTA
    Postal Code
    368001
    Country
    SG
    Correspondent
    STEPHEN H GORSKI

    US Agent

    Business Name
    Imagenix, Inc.
    Contact Name
    Stephen Gorski
    Address
    S65W35739 Piper Road
    City
    Eagle
    State
    WI
    ZIP
    53119
    Country
    US
    Email
    [email protected]
    Phone
    414 7374596

    Products

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

    Proprietary Names

    My-BP BP Management Application Software Healthstats A-Pulse CASPal Monitor MC3100+ Monitor

    Establishment Types

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