BEUDAMED
    FDA Registration Active 🇨🇳 China

    DRAWING BRD FOR NEB-A-DOODLE

    Reg #: 3003781173 · FEI: 3003781173 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD
    Registration Number
    3003781173
    FEI Number
    3003781173
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No 4 and No 8 Plants 9 Shenghui South Road, Nantou Town
    City
    Zhongshan City Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K091272

    Owner / Operator

    Firm Name
    Zhongshan A&E Machinery Industry Co., LTD
    Operator Number
    10049449
    Address
    No 4 and No 8 Plants 9 Shenghui South Rd, Nantou Town
    City
    Zhongshan City
    State
    Guangdong
    Postal Code
    510000
    Country
    CN

    US Agent

    Business Name
    Regulatory Insight, Inc.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    DRAWING BRD FOR NEB-A-DOODLE NEB-U-TYKE IC - PENGUIN NEB-U-TYKE TRAIN DISPLAY REPL FILTER FOR NEB-A-DOODLE ACCESSORY KIT (PEN,STAR,HEART) RPLCMT BUMPER NEB-U-TYKE TRAIN FILTER PACK FOR NEB SPEEDSTER FILTER FOR NEB PENGUIN & EV NEB-U-TYKE RR TRAIN FILTER PK FOR NEB-U-TYKE TRAIN NEB-U-LITE EV 12/CS NEB-U-TYKE NEB-A-DOODLE NEB-U-TYKE SPEEDSTER NEBULIZER CUP EACH FILTER CAPS FOR EV NEB NEB-U-TYKE IGLOO DISPLAY CABINET FILTER FOR OPTIUM RESERVOIR TUBE FOR NEB SPEEDST FILTER CAPS NEB-U-TYKE TRAIN FILTER CAP FOR NEB-A-DOODLE NEB-U-TYKE RACETRACK DISPLAY

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device