BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BIODYNE

    Reg #: 3011496777 · FEI: 3011496777 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    23
    Establishment Types
    1
    Classifications
    5

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    Registration Details

    Registration Name
    BIODYNE
    Registration Number
    3011496777
    FEI Number
    3011496777
    Status
    Active
    Expiry Year
    2026
    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
    Preservative, Cytological LEA
    Filters, Cell Collection, Tissue Processing KET
    Slides, Microscope KEW
    Applicator, Absorbent Tipped, Sterile KXG
    Fixative, Alcohol Containing LDZ

    Proprietary Names

    PATHPLORER Dilute Solution PATHPLORER Cervical Oral Solution PATHPLORER Urine-CSF Solution PATHPLORER Non-Gyn Lysis Solution PATHPLORER Gyn Lysis Solution PATHPLORER Urine Bottle PATHPLORER Body Fluid-FNA Solution PATHPLORER Respiratory Tract Solution Cellprep Membrane Filter PATHPLORER Membrane Filter Cellprep Coated Microscope Slide PATHPLORER Coated Microscope Slide Earlypap Self-Test Kit Earlypap Brush Cellprep Non-Gyn Lysis Solution Cellprep Urine Bottle Cellprep Gyn Lysis Solution Cellprep Cervical Oral Solution Cellprep Urine-CSF Solution Cellprep Urine direct Solution Cellprep Body Fluid-FNA Solution Cellprep Dilute Solution Cellprep Respiratory Tract Solution

    Establishment Types

    Manufacture Medical Device