BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Sera

    Reg #: 2113281 · FEI: 2113281 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    DIAGNOSTIC GROUP LLC
    Registration Number
    2113281
    FEI Number
    2113281
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    10395 W 70th St
    City
    EDEN PRAIRIE
    State
    MN
    ZIP
    55344
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173567

    Owner / Operator

    Firm Name
    DEMANT A/S
    Operator Number
    8010048
    Address
    KONGEBAKKEN 9, --
    City
    SMORUM
    State
    DK-NOTA
    Postal Code
    DK-2765
    Country
    DK

    Products

    Device Name Product Code
    Audiometer EWO
    Stimulator, Auditory, Evoked Response GWJ

    Proprietary Names

    Sera

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198