BEUDAMED
    FDA Registration Active 🇩🇰 Denmark

    Neuroline 715

    Reg #: 9610691 · FEI: 3002806359 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Ambu A/S
    Registration Number
    9610691
    FEI Number
    3002806359
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Baltorpbakken 13
    City
    Ballerup Hovedstaden
    Country
    DK

    Regulatory Submissions

    510(k) Number
    K931426

    Owner / Operator

    Firm Name
    AMBU A/S
    Operator Number
    8010067
    Address
    13 BALTORPBAKKEN, --
    City
    BALLERUP
    State
    DK-NOTA
    Postal Code
    DK-2750
    Country
    DK

    US Agent

    Business Name
    Ambu Inc
    Contact Name
    Sanjay Parikh
    Address
    6721 Columbia Gateway Drive, Suite 200
    City
    Columbia
    State
    MD
    ZIP
    21046
    Country
    US
    Email
    [email protected]
    Phone
    410 7686464 ext. 1136

    Products

    Device Name Product Code
    Electrode, Cutaneous GXY

    Proprietary Names

    Neuroline 715 Neuroline

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility