BEUDAMED
    FDA Registration Active 🇨🇳 China

    Stryker 8001 Series Foley Catheter Temperature Probe

    Reg #: 3003903031 · FEI: 3003903031 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WELL LEAD MEDICAL CO. LTD
    Registration Number
    3003903031
    FEI Number
    3003903031
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    C-4 JINHU INDUSTRIAL ESTATE, HUALONG, PAN YU
    City
    GUANGZHOU Guangdong
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K921561

    Owner / Operator

    Firm Name
    WELL LEAD MEDICAL CO. LTD
    Operator Number
    9045441
    Address
    No.47 Guomao Avenue South, HUALONG, PAN YU
    City
    GUANGZHOU
    State
    Guangdong
    Postal Code
    511434
    Country
    CN
    Correspondent
    Jenny Zhu

    US Agent

    Business Name
    MID-LINK INTERNATIONAL CO., Ltd
    Contact Name
    Marco Mu
    Address
    2219 Rimlang Drive, Suite 301
    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

    Stryker 8001 Series Foley Catheter Temperature Probe Philips Foley Catheter Temperature Probe MEAS 4400 Series Foley Catheter Temperature Probe

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)