BEUDAMED
    FDA Registration Active 🇮🇪 Ireland

    Dantec Keypoint 9031A0701 9033A0701 9033A0711 9033A0721 9033G0704 9031C0732 9031C0742 9031C0762 9031C0771 9031C0782 9033

    Reg #: 3005581270 · FEI: 3005581270 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Natus Manufacturing Limited
    Registration Number
    3005581270
    FEI Number
    3005581270
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    IDA BUSINESS PARK
    City
    GORT, Co. Galway
    Country
    IE

    Regulatory Submissions

    510(k) Number
    K944547

    Owner / Operator

    Firm Name
    Natus Medical Incorporated
    Operator Number
    9004873
    Address
    3150 Pleasant View Road
    City
    Middleton
    State
    WI
    Postal Code
    53562
    Country
    US

    US Agent

    Business Name
    Natus
    Contact Name
    Courtney Walton
    Address
    3610 County Road 101 S
    City
    Wayzata
    State
    MN
    ZIP
    55391
    Country
    US
    Email
    [email protected]
    Phone
    651 4215870

    Products

    Device Name Product Code
    Stimulator, Electrical, Evoked Response GWF

    Proprietary Names

    Dantec Keypoint 9031A0701 9033A0701 9033A0711 9033A0721 9033G0704 9031C0732 9031C0742 9031C0762 9031C0771 9031C0782 9033 Keypoint Focus STIMULATOR, ELECTRICAL, EVOKED RESPONSE 9031E0712 9031E0722 9031E0172 9031F1124 9031E0155 Keypoint Portable Keypoint G4 9031D0401 9031D0411 9031E0223 9013L0241 Keypoint 4 9031E0172 9031F1124 9031E0155

    Establishment Types

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