BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    CLASSYS INC

    Reg #: 3012259264 · FEI: 3012259264 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CLASSYS INC
    Registration Number
    3012259264
    FEI Number
    3012259264
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    208, Teheran-ro, Gangnam-gu
    City
    Republic of Korea Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K230100

    Owner / Operator

    Firm Name
    CLASSYS INC
    Operator Number
    10051595
    Address
    CLASSYS, 208, Teheran-ro, Gangnam-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    06220
    Country
    KR

    Products

    Device Name Product Code
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    SCIZER Volnewmer

    Establishment Types

    Manufacture Medical Device