BEUDAMED
    FDA Registration Active 🇨🇳 China

    Latex Foley Catheter

    Reg #: 3027301746 · FEI: 3027301746 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WELL LEAD MEDICAL (HAINAN) CO., LTD.
    Registration Number
    3027301746
    FEI Number
    3027301746
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park, 571157 ,Haikou, Hainan, China
    City
    Haikou Hainan
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K082815

    Owner / Operator

    Firm Name
    Well Lead Medical (Hainan) Co., Ltd.
    Operator Number
    10087515
    Address
    No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park, 571157 ,Haikou, Hainan, China
    City
    Haikou
    State
    Hainan
    Postal Code
    570000
    Country
    CN
    Correspondent
    Xiao Qing Zhao

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., LTD
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301, Bellingham,Barkley Villiage
    City
    Bellingham
    State
    WA
    ZIP
    98226
    Country
    US
    Email
    [email protected]
    Phone
    702 2095185

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Latex Foley Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)