BEUDAMED
    FDA Registration Active 🇨🇳 China

    KZ0830H0

    Reg #: 3011347300 · FEI: 3011347300 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    122
    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
    K241888

    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
    Dilator, Esophageal KNQ
    Stents, Drains And Dilators For The Biliary Ducts FGE

    Proprietary Names

    KZ0830H0 KZ1030H3 KZ1255G1 Single-use Balloon Dilatation Catheter KZ1855H1 KZ0855G0 KZ1030H0 KZ1055H0 KZ1530H1 KZ0630E0 KZ0855G3 KZ1055G3 KZ0680H0 KZ0655H0 BX00715512W KZ1080F0 BX00718018W KZ1880H0 KZ1555H3 KZ0680H3 KZ0630E3 KZ0830H1 KZ1880H1 BX00715506W KZ1230E1 KZ1030E0 KZ1855H3 KZ1255H1 KZ1280H0 KZ0655G1 KZ0855G1 KZ1055G0 BX00718015W KZ1880F1 BX00715515W KZ0880H3 KZ0830E1 BX00715515 KZ1880H3 KZ1255G0 KZ1580H3 KZ0655G0 KZ0880F1 KZ1855G3 KZ0630E1 KZ0655H3 KZ1580F0 KZ0855H1 KZ1255H3 BX00718008W KZ0880H0 BX00715508W BX00715518W KZ0655H1 BX00715510 KZ1555G3 BX00715506 KZ1555H0 KZ1280F1 KZ1030H1 KZ1555H1 KZ0830E0 KZ1555G0 BX00715508 BX00718012W KZ1055H3 KZ1855H0 KZ0680F1 KZ0855H0 KZ0680H1 BX00718010W KZ1080F3 KZ1230E0 KZ1855G0 KZ1530H0 KZ1230E3 KZ1280F0 KZ1055H1 KZ0855H3 KZ0830E3 KZ1055G1 KZ1555G1 KZ1530E3 KZ1230H1 KZ1880F3 KZ1080H0 KZ1080H1 LUMIFLEXTM 3-Stage Balloon Dilatation Catheter KZ1580F1 KZ1030E1 KZ1230H3 KZ0630H3 KZ1280F3 KZ1080H3 BX00715518 KZ1530E1 KZ1255H0 BX00718006W KZ1530E0 KZ1530H3 KZ1580F3 KZ1855G1 KZ0680F0 KZ1280H3 BX00715512 KZ0630H0 KZ1580H1 KZ1880F0 KZ0680F3 KZ1230H0 KZ1280H1 BX00715510W KZ0630H1 KZ1255G3 KZ0655G3 KZ0880F3 KZ1580H0 KZ0830H3 KZ1030E3 KZ0880F0 KZ0880H1 KZ1080F1

    Establishment Types

    Manufacture Medical Device