BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CHUNGWOO CO., LTD.

    Reg #: 3010952064 · FEI: 3010952064 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    31
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CHUNGWOO CO., LTD.
    Registration Number
    3010952064
    FEI Number
    3010952064
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    (Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro
    City
    Geumcheon-gu Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K222709

    Owner / Operator

    Firm Name
    CHUNGWOO CO., LTD.
    Operator Number
    10087784
    Address
    (Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro
    City
    Geumcheon-gu
    State
    Seoul
    Postal Code
    08591
    Country
    KR
    Correspondent
    IL KWON LEE

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    Jung Ryun Ahn
    Address
    115 East 34th street, 13J
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    646 3576058

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Electrode LIFT (Model: 2X80) Neutral Pad (Model: 9541C) Neutral Cable (Model: CWM-910T-H22-1) Hand Piece SMART (Model: HP20-180) Hand Piece LIPO (Model: HP40-300) APOLEX Tite (Model: CWM-910T) Hand Piece Electrode LIPO (Model: AE40-300) Foot Switch (Model: CWM-910T-H21) Electrode LIPO (Model: 4X300) Power cable (Models: SP-30H, IS-14) Electrode SMART (Model: 2X180) Revive (Model: CWM-910T) Retraction (Model: CWM-910T) Hand Piece LIFT (Model: HP20-80) Hand Piece Electrode SMART (Model: AE20-180) Hand Piece Electrode LIFT (Model: AE20-80) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C25, CWM-930S_ELLISYS ST-S25) Foot Switch (Model: CWM-930S-H13) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C49, CWM-930S_ELLISYS ST-S49) Bi-polar Hand piece Cable (Model: CWM-930S-H20) Bi-polar Hand piece (Model: CWM-930S-Y01) Bi-polar Hand piece Suction Filter (Model: CWM-930S-Y02) Neutral Pad (Model: 9571C) ELLISYS SENSE (Model: CWM-930S) FIXER DV9 (Model: CWM-930S) Sterile Micro Needle (Model: CWM-930S_ELLISYS TIP-1) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C14, CWM-930S_ELLISYS ST-S14) Neutral Cable (Model: CWM-930S-H37) Mono-polar Hand piece (Model: CWM-930S-Y03) Sterile Micro Needle ELLISYS ST (Model: CWM-930S_ELLISYS ST-S36) Power Cable (Model: SP-30H, IS-14)

    Establishment Types

    Manufacture Medical Device