BEUDAMED
    FDA Registration Active 🇲🇾 Malaysia

    Neuroline

    Reg #: 3004040397 · FEI: 3004040397 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    AMBU SDN.BHD.
    Registration Number
    3004040397
    FEI Number
    3004040397
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    LOT 69-B, Lintang Bayan Lepas 6, Phase IV
    City
    PENANG Pulau Pinang
    Country
    MY

    Regulatory Submissions

    510(k) Number
    K020907

    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, Needle GXZ
    Electrode, Needle, Diagnostic Electromyograph IKT

    Proprietary Names

    Neuroline Neuroline Twisted Pair Subdermal Needle Electrode Neuroline Subdermal Needle Electrode Twisted Pair Subdermal Needle Electrode Subdermal Needle Electrode

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)