BEUDAMED
    FDA Registration Active 🇨🇳 China

    Nebulizer

    Reg #: 3013000203 · FEI: 3013000203 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN HOMED MEDICAL DEVICE CO LTD
    Registration Number
    3013000203
    FEI Number
    3013000203
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Block 5, 2 Anyue Road, Chashan Town,Dongguan City 523393, Guangdong Province, People's Republic of China
    City
    Dongguan Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K150591

    Owner / Operator

    Firm Name
    Jarlung(H.K.)Industries Limited
    Operator Number
    10041952
    Address
    Room1601to1614,ABuilding,JinxiuIII,No.85HudiPaiSongxuanCommunity,GuanhuStreet,Longhua District,Shenzhen, Shenzhen City Guangdong, CHINA 518109
    City
    shenzhen
    State
    Guangdong
    Postal Code
    518109
    Country
    CN
    Correspondent
    Shengming Shi

    US Agent

    Business Name
    CTI US lnc.
    Contact Name
    Robin Zhang
    Address
    1455 Lincoln Pkwy E Ste 230
    City
    Atlanta
    State
    GA
    ZIP
    30346
    Country
    US
    Email
    [email protected]
    Phone
    313 2885666

    Products

    Device Name Product Code
    Nebulizer (Direct Patient Interface) CAF

    Proprietary Names

    Nebulizer

    Establishment Types

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