BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    TERA HARZ CLEAR (TC-85DAC, TR-07, TA-28)

    Reg #: 3015302693 · FEI: 3015302693 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Graphy Inc.
    Registration Number
    3015302693
    FEI Number
    3015302693
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    #603, #617, Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K240597

    Owner / Operator

    Firm Name
    Graphy, Inc.
    Operator Number
    10061702
    Address
    #603, #617 Ace Gasan Forhu, 225, Gasan digital 1-ro, Geumcheon-gu
    City
    Seoul
    State
    KR-11
    Postal Code
    08501
    Country
    KR
    Correspondent
    Un-seob Sim

    US Agent

    Business Name
    SMB USA LLC.
    Contact Name
    HUICHAO LEE
    Address
    44855 LAFAYETTE DR
    City
    NOVI
    State
    MI
    ZIP
    48377
    Country
    US
    Email
    [email protected]
    Phone
    734 3671285

    Products

    Device Name Product Code
    Aligner, Sequential NXC

    Proprietary Names

    TERA HARZ CLEAR (TC-85DAC, TR-07, TA-28)

    Establishment Types

    Manufacture Medical Device