BEUDAMED
    FDA Registration Active 🇨🇳 China

    CO2 Laser Therapy Systems

    Reg #: 3014388884 · FEI: 3014388884 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    BEIJING SEA HEART INTERNATIONAL SCIENCE AND TECHNOLOGY CO.,LTD.
    Registration Number
    3014388884
    FEI Number
    3014388884
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Room 4009, Building 4, Zhongke Jingwei Industrial Park, No. 8 Yongchang Middle Road, Economic and Technological Development Zone,
    City
    Beijing
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K162398

    Owner / Operator

    Firm Name
    Beijing Sea Heart International Science And Technology Co.,L
    Operator Number
    10062040
    Address
    Room 4009, Building 4, Zhongke Jingwei Industrial Park, No. 8 Yongchang Middle Road, Economic and Technological Development Zone,
    City
    Beijing
    State
    CN-BJ
    Postal Code
    100176
    Country
    CN
    Correspondent
    Kun Yang

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    CO2 Laser Therapy Systems

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device