BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    ACR

    Reg #: 3005515228 · FEI: 3005515228 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BIOMATERIALS KOREA INC.
    Registration Number
    3005515228
    FEI Number
    3005515228
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #413 #329 #331 150, Jojeong-daero
    City
    Hanam-si Gyeonggi
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K063495

    Owner / Operator

    Firm Name
    BIOMATERIALS KOREA INC.
    Operator Number
    9080640
    Address
    #413 #329 #331 150, Jojeong-daero
    City
    Hanam-si
    State
    Gyeonggi
    Postal Code
    0
    Country
    KR

    US Agent

    Business Name
    REGULATORY INSIGHT, INC.
    Contact Name
    Kevin Walls
    Address
    33 Golden Eagle Lane
    City
    Littleton
    State
    CO
    ZIP
    80127
    Country
    US
    Email
    [email protected]
    Phone
    720 9625412

    Products

    Device Name Product Code
    Implant, Endosseous, Orthodontic OAT

    Proprietary Names

    ACR

    Establishment Types

    Manufacture Medical Device