BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    SCIZER

    Reg #: 3012259264 · FEI: 3012259264 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CLASSYS INC
    Registration Number
    3012259264
    FEI Number
    3012259264
    Status
    Active
    Expiry Year
    2025
    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

    US Agent

    Business Name
    Elexes Medical Consulting LLC
    Contact Name
    Dana S
    Address
    218 Eclipse Drive
    City
    Bordentown
    State
    NJ
    ZIP
    08505
    Country
    US
    Email
    [email protected]
    Phone
    732 6475105 ext. 1

    Products

    Device Name Product Code
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV

    Proprietary Names

    SCIZER

    Establishment Types

    Manufacture Medical Device