BEUDAMED
    FDA Registration Active 🇨🇳 China

    OneCath Intermittent Urinary Catheter

    Reg #: 3003717263 · FEI: 3003717263 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    JIANGSU SUYUN MEDICAL MATERIALS CO., LTD.
    Registration Number
    3003717263
    FEI Number
    3003717263
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    No.18, Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone
    City
    Lianyungang Jiangsu
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K180738

    Owner / Operator

    Firm Name
    Jiangsu Suyun Medical Materials Co., Ltd.
    Operator Number
    10029900
    Address
    No.18,Jinqiao Road, Dapu Industrial Park, Lianyungang Economic Development Zone
    City
    Lianyungang
    State
    Jiangsu
    Postal Code
    222002
    Country
    CN
    Correspondent
    Xu Guang Ning

    US Agent

    Business Name
    Performance International, Corp.
    Contact Name
    Dennis Xu
    Address
    4004 Pepperton Dr.
    City
    Raleigh
    State
    NC
    ZIP
    27606
    Country
    US
    Email
    [email protected]
    Phone
    919 8590478

    Products

    Device Name Product Code
    Catheter, Coude EZC
    Catheter, Straight EZD

    Proprietary Names

    OneCath Intermittent Urinary Catheter OneCath Lubricated Intermittent Urinary Catheter

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)