BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    BIO OPTICS CO., LTD.

    Reg #: 3017609685 · FEI: 3017609685 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    3

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    Registration Details

    Registration Name
    BIO OPTICS CO., LTD.
    Registration Number
    3017609685
    FEI Number
    3017609685
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    14, Galmachi-ro, 288beon-gil
    City
    Seongnam Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K241229

    Owner / Operator

    Firm Name
    Bio Optics Co., Ltd.
    Operator Number
    10077954
    Address
    14, Galmachi-ro, 288beon-gil
    City
    Seongnam
    State
    Gyeonggi
    Postal Code
    13201
    Country
    KR
    Correspondent
    Seo Hongryul

    US Agent

    Business Name
    KMC USA, Inc
    Contact Name
    Jung Ryun Ahn
    Address
    115 East 34th street, 13J
    City
    New York
    State
    NY
    ZIP
    10016
    Country
    US
    Email
    [email protected]
    Phone
    646 3576058

    Products

    Device Name Product Code
    Knife, Ophthalmic HNN
    Strip, Schirmer KYD
    Plug, Punctum LZU

    Proprietary Names

    Hello, eyes - BIO Surgical Knife Hello, eyes - BIO Color Tear Test Hello,eyes (Bio Plug 0.3, Bio Plug 0.4, Bio Plug 0.5)

    Establishment Types

    Manufacture Medical Device