BEUDAMED
    FDA Registration Active 🇨🇳 China

    WELL LEAD MEDICAL (HAINAN) CO., LTD.

    Reg #: 3027301746 · FEI: 3027301746 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    WELL LEAD MEDICAL (HAINAN) CO., LTD.
    Registration Number
    3027301746
    FEI Number
    3027301746
    Status
    Active
    Expiry Year
    2026
    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
    K233094

    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
    Regrek LLC
    Contact Name
    Leeyeo Kee
    Address
    19 Holly Cove Ln
    City
    Dover
    State
    DE
    ZIP
    19901
    Country
    US
    Email
    [email protected]
    Phone
    302 6089028

    Products

    Device Name Product Code
    Catheter, Ureteral, Gastro-Urology EYB
    Catheter, Urological (Antimicrobial) And Accessories MJC
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Wellead Latex Foley Catheter AMSure Silicone Coated Latex Foley Catheter Latex Foley Catheter AMSure Red Rubber Urethral Catheter

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)