BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    Earlypap Self-Test Kit

    Reg #: 3011496777 · FEI: 3011496777 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIODYNE
    Registration Number
    3011496777
    FEI Number
    3011496777
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    24-4 Achasan-ro, 5-gil, Seongdong-gu
    City
    Seoul
    Country
    KR

    Owner / Operator

    Firm Name
    Biodyne
    Operator Number
    10047880
    Address
    24-4 Achasan-ro, 5-gil, Seongdong-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    04793
    Country
    KR
    Correspondent
    Wookbin Im

    US Agent

    Business Name
    HSchem America
    Contact Name
    Won Woo Suh
    Address
    1717 Chantilly Ln
    City
    Fullerton
    State
    CA
    ZIP
    92833
    Country
    US
    Email
    [email protected]
    Phone
    213 5597719

    Products

    Device Name Product Code
    Applicator, Absorbent Tipped, Sterile KXG

    Proprietary Names

    Earlypap Self-Test Kit Earlypap Brush

    Establishment Types

    Manufacture Medical Device