BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    TENTECH INC.

    Reg #: 3025606176 · FEI: 3025606176 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    TENTECH INC.
    Registration Number
    3025606176
    FEI Number
    3025606176
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    #802 Ace Techno Tower 5th, 20, Digital-ro 31-gil, Guro-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K220794

    Owner / Operator

    Firm Name
    TENTECH Inc.
    Operator Number
    10086925
    Address
    326, Bongeunsa-ro, Gangnam-gu, 4F, 5F
    City
    Seoul
    State
    KR-11
    Postal Code
    06143
    Country
    KR
    Correspondent
    DONG OK HAN

    US Agent

    Business Name
    BT Solutions USA, LLC
    Contact Name
    Do Hyun Kim
    Address
    7816 Blue Ribbon Street
    City
    Fulton
    State
    MD
    ZIP
    20759
    Country
    US
    Email
    [email protected]
    Phone
    410 2949140

    Products

    Device Name Product Code
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    10PL XTHERMA 10THERMA

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device