BEUDAMED
    FDA Registration Active 🇨🇳 China

    Silicone Foley Catheter

    Reg #: 3006787036 · FEI: 3006787036 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Hangzhou Fushan Medical Appliance Co., Ltd.
    Registration Number
    3006787036
    FEI Number
    3006787036
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.1288 South Jinxi Road, Linglong Industrial Park, Lin'an District
    City
    Hangzhou City Zhejiang
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K023808

    Owner / Operator

    Firm Name
    Hangzhou Fushan Medical Appliance Co., Ltd.
    Operator Number
    10022911
    Address
    No.1288 South Jinxi Road, Linglong Industry Park
    City
    Lin'an, Hangzhou
    State
    Zhejiang
    Postal Code
    311301
    Country
    CN
    Correspondent
    Heather Qin

    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
    System, Irrigation, Urological LJH
    Arthroscope HRX

    Proprietary Names

    Silicone Foley Catheter IRRIGATION

    Establishment Types

    Repack or Relabel Medical Device