BEUDAMED
    FDA Registration Active 🇬🇧 United Kingdom

    HeartKey® Rhythm

    Reg #: 3031786139 · FEI: 3031786139 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    B-SECUR LIMITED
    Registration Number
    3031786139
    FEI Number
    3031786139
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    11th Floor, City Quays 3, 92 Donegall Quay
    City
    Belfast
    Country
    GB

    Regulatory Submissions

    510(k) Number
    K233755

    Owner / Operator

    Firm Name
    B-Secur Limited
    Operator Number
    10093270
    Address
    11th Floor, City Quays 3, 92 Donegall Quay
    City
    Belfast
    State
    GB-BFS
    Postal Code
    BT1 3FE
    Country
    GB
    Correspondent
    Cameron Moore

    US Agent

    Business Name
    MDQR LLC
    Contact Name
    Prabhu Raghavan
    Address
    1790 Montemar Way
    City
    San Jose
    State
    CA
    ZIP
    95125
    Country
    US
    Email
    [email protected]
    Phone
    408 3165707

    Products

    Device Name Product Code
    Computer, Diagnostic, Programmable DQK
    Electrocardiograph DPS

    Proprietary Names

    HeartKey® Rhythm

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device