BEUDAMED
    FDA Registration Active 🇵🇱 Poland

    Ear tip, ER10C-03

    Reg #: 3011310592 · FEI: 3011310592 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    DGS Diagnostics Sp. z o.o
    Registration Number
    3011310592
    FEI Number
    3011310592
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Rosowek 43
    City
    Kolbaskowo Zachodniopomorskie
    Country
    PL

    Regulatory Submissions

    510(k) Number
    K930553

    Owner / Operator

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

    US Agent

    Business Name
    Grason-Stadler
    Contact Name
    Brandon Bell
    Address
    10395 West 70th Street
    City
    Eden Prairie
    State
    MN
    ZIP
    55344
    Country
    US
    Email
    [email protected]
    Phone
    952 9476097

    Products

    Device Name Product Code
    Audiometer EWO

    Proprietary Names

    Ear tip, ER10C-03 Foam ear tip, 10 mm, ER10C Foam ear tip, 10 mm, ER1/ER2 Foam ear tip, 13 mm, ER10B+ Foam ear tip, 13 mm, ER10C Foam ear tip, 18 mm, ER10C ER-2 Insert Earphones Foam ear tip, 13 mm, ER1/ER2 Ear tip, ER10C-06 Ear tip, ER10C-05 Ear tip, ER10C-04

    Establishment Types

    Manufacture Medical Device