BEUDAMED
    FDA Registration Active 🇿🇦 South Africa

    Sensi Diagnostic Heart Murmur Software

    Reg #: 3010148504 · FEI: 3010148504 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Diacoustic Medical Devices Pty Ltd
    Registration Number
    3010148504
    FEI Number
    3010148504
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    24 Gardner Williams Ave, Paardevlei
    City
    Somerset West Western Cape
    Country
    ZA

    Regulatory Submissions

    510(k) Number
    K121617

    Owner / Operator

    Firm Name
    Diacoustic Medical Devices Pty Ltd
    Operator Number
    10042123
    Address
    Electron Street, Octo Place A3, Techno Park
    City
    Stellenbosch
    State
    Western Cape
    Postal Code
    7600
    Country
    ZA

    US Agent

    Business Name
    Smith Associates
    Contact Name
    Kristi Leigh
    Address
    1468 Harwell Ave
    City
    Crofton
    State
    MD
    ZIP
    21114
    Country
    US
    Email
    [email protected]
    Phone
    888 7299674

    Products

    Device Name Product Code
    Stethoscope, Electronic DQD

    Proprietary Names

    Sensi Diagnostic Heart Murmur Software

    Establishment Types

    Manufacture Medical Device