BEUDAMED
    FDA Registration Active 🇸🇬 Singapore

    BProSOft BT PC Software

    Reg #: 3006551178 · FEI: 3006551178 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    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
    K173028

    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

    BProSOft BT PC Software BPro BT Ambulatory Blood Pressure Monitoring System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device