BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ABPMpro Ambulatory Blood Pressure Recorder

    Reg #: 3006258337 · FEI: 3006258337 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    SOMNOMEDICS AG
    Registration Number
    3006258337
    FEI Number
    3006258337
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    AM SONNENSTUHL 63
    City
    RANDERSACKER Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K231104

    Owner / Operator

    Firm Name
    SOMNOmedics AG
    Operator Number
    9084423
    Address
    AM SONNENSTUHL 63
    City
    RANDERSACKER
    State
    DE-NOTA
    Postal Code
    97236
    Country
    DE

    US Agent

    Business Name
    M Squared Associates/a PPG Company
    Contact Name
    Cherita James
    Address
    1129 20th St NW, Suite 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    ABPMpro Ambulatory Blood Pressure Recorder

    Establishment Types

    Manufacture Medical Device