BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    HANDAE CHEMICAL CO., LTD

    Reg #: 3004605596 · FEI: 3004605596 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    10
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    HANDAE CHEMICAL CO., LTD
    Registration Number
    3004605596
    FEI Number
    3004605596
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    56-28, Songdu 4-gil, Jincheon-eup
    City
    Jincheon-gun Chungbuk
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K140966

    Owner / Operator

    Firm Name
    Handae Chemical Co., Ltd
    Operator Number
    10035933
    Address
    56-28, Songdu 4-gil, Jincheon-eup
    City
    Jincheon-gun
    State
    Chungbuk
    Postal Code
    27845
    Country
    KR

    US Agent

    Business Name
    Onbix Corp US
    Contact Name
    Krallum Uju
    Address
    102 N G St Unit 105
    City
    Tacoma
    State
    WA
    ZIP
    98403
    Country
    US
    Email
    [email protected]
    Phone
    843 5828036

    Products

    Device Name Product Code
    Material, Impression ELW
    Material, Impression Tray, Resin EBH

    Proprietary Names

    Delikit Bite Registration Premium PERFECT-F VPS PUTTY VINYLATE PERFECT-F VPS REGULAR BODY PERFECT-F VPS HEAVY BODY PERFECT-F VPS FIT CHECKER PERFECT-F VPS LIGHT BODY PERFECT BITE Delikit Light Body Premium Delikit Heavy Body Premium

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device