BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    FORTUNA HELIX

    Reg #: 3038181305 · FEI: 3038181305 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    FORTUNA HELIX
    Registration Number
    3038181305
    FEI Number
    3038181305
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Seoul Biohub Global Center, Suite 502, 117-3 Hoegi-ro, Dongdaemun-gu
    City
    Seoul
    Country
    KR

    Owner / Operator

    Firm Name
    Fortuna Helix
    Operator Number
    10093089
    Address
    Seoul Biohub Global Center, Suite 502, 117-3 Hoegi-ro, Dongdaemun-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    02455
    Country
    KR
    Correspondent
    Bermseok Oh

    Products

    Device Name Product Code
    Genetic Variant Detection And Health Risk Assessment System PTA

    Proprietary Names

    Fortuna Helix GenPredict: Disease

    Establishment Types

    Manufacture Medical Device