BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Human-broncho endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R)

    Reg #: 3013023209 · FEI: 3013023209 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    INSUNG MEDICAL CO., LTD.
    Registration Number
    3013023209
    FEI Number
    3013023209
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    168, GIEOPDOSI-RO, JIJEONG-MYEON
    City
    WONJU-SI Gangwon
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K200968

    Owner / Operator

    Firm Name
    INSUNG MEDICAL CO., LTD.
    Operator Number
    10078318
    Address
    168, GIEOPDOSI-RO, JIJEONG-MYEON
    City
    WONJU-SI
    State
    Gangwon
    Postal Code
    26354
    Country
    KR
    Correspondent
    Song Inkeum

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    SEOK WOO KIM
    Address
    5450 ASTOR LANE #203
    City
    Rolling Mdws
    State
    IL
    ZIP
    60008
    Country
    US
    Email
    [email protected]
    Phone
    847 9241545

    Products

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

    Proprietary Names

    Human-broncho endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R) ANKOR endobronchial tube (Models: ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R) ANKOR endobronchial tube (Models: HBC33L, HBC35L, HBC37L, HBC39L, HBC33R, HBC35R, HBC37R, HBC39R)

    Establishment Types

    Manufacture Medical Device