BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    Otoread

    Reg #: 3002504821 · FEI: 3002504821 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    MAICO Diagnostics GmbH
    Registration Number
    3002504821
    FEI Number
    3002504821
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sickingenstr. 70-71
    City
    Berlin
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K150491

    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

    Proprietary Names

    Otoread EroScan Plus

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device