BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SUTURE

    Reg #: 3016445763 · FEI: 3016445763 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SKIDYWORKS INTERNATIONAL CO., LTD
    Registration Number
    3016445763
    FEI Number
    3016445763
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #406 AFE Globaledu-ro 396-0, Daejeong - eup, Seogwipo-si
    City
    JEJU
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K160761

    Owner / Operator

    Firm Name
    SKIDYWORKS INTERNATIONAL CO., LTD
    Operator Number
    10062402
    Address
    #106, 301-26 Pyeonghwa-ro 89beon-gil,, Daejeong - eup, Seogwipo-si
    City
    JEJU
    State
    KR-NOTA
    Postal Code
    63519
    Country
    KR
    Correspondent
    Clive Seo

    US Agent

    Business Name
    CosmoFrance
    Contact Name
    Michael Grillo
    Address
    2121 Sw 3rd Ave Ste 500
    City
    Miami
    State
    FL
    ZIP
    33129
    Country
    US
    Email
    [email protected]
    Phone
    305 5380110

    Products

    Device Name Product Code
    Suture, Surgical, Absorbable, Polydioxanone NEW

    Proprietary Names

    SUTURE

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer) Manufacture Medical Device for Another Party (Contract Manufacturer)