BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SEJONG HEALTHCARE CO., LTD.

    Reg #: 3017398283 · FEI: 3017398283 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    6

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    Registration Details

    Registration Name
    SEJONG HEALTHCARE CO., LTD.
    Registration Number
    3017398283
    FEI Number
    3017398283
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1502-1 Tongil-ro, Paju-eup
    City
    Paju Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K220435

    Owner / Operator

    Firm Name
    SEJONG HEALTHCARE CO., LTD.
    Operator Number
    10075988
    Address
    1502-1 Tongil-ro, Paju-eup
    City
    Paju
    State
    Gyeonggi
    Postal Code
    10836
    Country
    KR
    Correspondent
    KYU NAM HWANG

    US Agent

    Business Name
    CGETC, INC.
    Contact Name
    DAVID BYUN
    Address
    18400 San Jose Ave
    City
    City Industry
    State
    CA
    ZIP
    91748
    Country
    US
    Email
    [email protected]
    Phone
    909 2612252

    Products

    Device Name Product Code
    Accessory, Surgical Apparel LYU
    Drape, Surgical, Exempt PUI
    Non-Surgical Gown OEA
    Gown, Examination FME
    Bedding, Disposable, Medical KME
    Gown, Surgical FYA

    Proprietary Names

    Isolation Gown Dental Mask H Non-Surgical Gown Dental Mask W Cover Gown Dental Bibs Surgical Drapes and Accessories Equipment Covers Surgical Drape Accessories Surgical Packs Surgical Drapes Surgical Drape Sterile Wraps Back Table Covers Endoscopy Gown Endoscopy Pants Patient Exam Gown Patient Exam Pants Pillow Cover Bed Sheets SEJONG Surgical Gown Soft

    Establishment Types

    Manufacture Medical Device