BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SOMNOMEDICS AG

    Reg #: 3006258337 · FEI: 3006258337 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    13
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    SOMNOMEDICS AG
    Registration Number
    3006258337
    FEI Number
    3006258337
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    AM SONNENSTUHL 63
    City
    RANDERSACKER Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K240700

    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
    Pro Pharma Group
    Contact Name
    Cherita James
    Address
    1129 20th St Nw Ste 600
    City
    Washington
    State
    DC
    ZIP
    20036
    Country
    US
    Email
    [email protected]
    Phone
    347 9540624

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR
    Standard Polysomnograph With Electroencephalograph OLV
    Media, Electroconductive GYB
    Recorder, Magnetic Tape, Medical DSH
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    HomeSleepTest (HST, HST REM+) EEG-acp Somnoscreen EEG 10-20 SOMNOscreen HD SOMNOscreen Eco SomnoScreen Plus SOMNOtouch RESP SOMNOtouch PSG SOMNOtouch RESP eco SomnoWatch ABPMpro Ambulatory Blood Pressure Recorder SOMNO SCREEN Somnoscreen Plus

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility