BEUDAMED
    FDA Registration Active 🇨🇳 China

    Ambu Spur II

    Reg #: 3003924186 · FEI: 3003924186 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    AMBU Limited
    Registration Number
    3003924186
    FEI Number
    3003924186
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.C,, Warehouse & Process Complex Building
    City
    XIANG YU F.T.Z., XIAMEN Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K152931

    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
    Ventilator, Emergency, Manual (Resuscitator) BTM

    Proprietary Names

    Ambu Spur II

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)