BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SomnoGuard SPX

    Reg #: 3006038700 · FEI: 3006038700 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Tomed GmbH
    Registration Number
    3006038700
    FEI Number
    3006038700
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Im Rapsfeld 57
    City
    Koeln North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K121761

    Owner / Operator

    Firm Name
    Tomed GmbH
    Operator Number
    9088701
    Address
    Im Rapsfeld 57, --
    City
    Köln
    State
    DE-NOTA
    Postal Code
    50933
    Country
    DE
    Correspondent
    Aylin Duesterhoeft

    US Agent

    Business Name
    1st. Line Medical, Inc.
    Contact Name
    Scott Whitcomb
    Address
    850 Route 3, Suite 201
    City
    Holderness
    State
    NH
    ZIP
    03245
    Country
    US
    Email
    [email protected]
    Phone
    603 8667208

    Products

    Device Name Product Code
    Device, Anti-Snoring LRK

    Proprietary Names

    SomnoGuard SPX SomnoGuard SP Pro SomnoGuard SP Soft

    Establishment Types

    Manufacture Medical Device