BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C14, CWM-930S_ELLISYS ST-S14)

    Reg #: 3010952064 · FEI: 3010952064 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    15
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CHUNGWOO CO., LTD.
    Registration Number
    3010952064
    FEI Number
    3010952064
    Status
    Active
    Expiry Year
    2025
    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
    K233120

    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
    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
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C14, CWM-930S_ELLISYS ST-S14) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C25, CWM-930S_ELLISYS ST-S25) Bi-polar Hand piece Cable (Model: CWM-930S-H20) Neutral Cable (Model: CWM-930S-H37) ELLISYS SENSE (Model: CWM-930S) Sterile Micro Needle (Model: CWM-930S_ELLISYS TIP-1) Sterile Micro Needle ELLISYS ST (Models: CWM-930S_ELLISYS ST-C49, CWM-930S_ELLISYS ST-S49) Neutral Pad (Model: 9571C) Mono-polar Hand piece (Model: CWM-930S-Y03) FIXER DV9 (Model: CWM-930S) Power Cable (Model: SP-30H, IS-14) Foot Switch (Model: CWM-930S-H13) Bi-polar Hand piece (Model: CWM-930S-Y01) Bi-polar Hand piece Suction Filter (Model: CWM-930S-Y02) Sterile Micro Needle ELLISYS ST (Model: CWM-930S_ELLISYS ST-S36)

    Establishment Types

    Manufacture Medical Device