BEUDAMED
    FDA Registration Active 🇨🇳 China

    Disposable Double Lumen Endobronchial Tube (Visible Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr)

    Reg #: 3013528571 · FEI: 3013528571 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    6
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
    Registration Number
    3013528571
    FEI Number
    3013528571
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Floor 13th, HTM Building, Ganli Road, Longgang District
    City
    Shenzhen Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K232529

    Owner / Operator

    Firm Name
    Shenzhen Insighters Medical Technology Co., Ltd.
    Operator Number
    10053495
    Address
    The 13th floor of Hengtemei Building,Ganli Road No. 3
    City
    Shenzhen
    State
    Guangdong
    Postal Code
    518000
    Country
    CN
    Correspondent
    Xiao Hua

    US Agent

    Business Name
    IRC USA
    Contact Name
    Charles Mack
    Address
    2950 E Lindrick Dr
    City
    Chandler
    State
    AZ
    ZIP
    85249
    Country
    US
    Email
    [email protected]
    Phone
    931 6254938

    Products

    Device Name Product Code
    Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector) CBI

    Proprietary Names

    Disposable Double Lumen Endobronchial Tube (Visible Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Visible Left Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Visible Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Visible Right Type B: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Ordinary Left Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr) Disposable Double Lumen Endobronchial Tube (Ordinary Right Type: 28 Fr, 32 Fr, 35 Fr, 37 Fr, 39 Fr, 41 Fr)

    Establishment Types

    Manufacture Medical Device