BEUDAMED
    FDA Registration Active 🇨🇳 China

    Loop40B0-LD165D0

    Reg #: 3011347300 · FEI: 3011347300 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    14
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    LEO MEDICAL CO., LTD.
    Registration Number
    3011347300
    FEI Number
    3011347300
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
    City
    Changzhou Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K172985

    Owner / Operator

    Firm Name
    Leo Medical Co., Ltd.
    Operator Number
    10092699
    Address
    No.10 Building, 23 Middle Huashan Road, Xinbei District, 213022, Changzhou City,, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA
    City
    Changzhou
    State
    Jiangsu
    Postal Code
    213022
    Country
    CN
    Correspondent
    Guojun Zhang

    US Agent

    Business Name
    Hlongmed International Ltd.
    Contact Name
    Anny Zhao
    Address
    1312 17th Street#692 Denver, CO 80202
    City
    Denver
    State
    CO
    ZIP
    80202
    Country
    US
    Email
    [email protected]
    Phone
    503 3344880

    Products

    Device Name Product Code
    Ligator, Esophageal MND
    Ligator, Hemorrhoidal FHN

    Proprietary Names

    Loop40B0-LD165D0 Loop40B0-LD230D0 Loop20B0-LD165D0 Loop30B0-LD230D0 Ligation Device Loop15B0-LD230D0 Loop15B0-LD165D0 EN10701 Loop30B0-LD195D0 Loop30B0-LD165D0 Loop15B0-LD195D0 Loop20B0-LD195D0 Loop40B0-LD195D0 Loop20B0-LD230D0

    Establishment Types

    Manufacture Medical Device