BEUDAMED
    FDA Registration Active 🇨🇳 China

    CATHWIDE MEDICAL CO.,LTD.

    Reg #: 3031175043 · FEI: 3031175043 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    CATHWIDE MEDICAL CO.,LTD.
    Registration Number
    3031175043
    FEI Number
    3031175043
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    305A Building 9, No. 1888 Xinjinqiao Road
    City
    Shanghai
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K130908

    Owner / Operator

    Firm Name
    Cathwide Medical Co.,Ltd.
    Operator Number
    10092546
    Address
    305A Building 9, No. 1888, Xinjinqiao Road
    City
    Shanghai
    State
    CN-NOTA
    Postal Code
    201206
    Country
    CN
    Correspondent
    XINLEI WEI

    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, Retention Type, Balloon EZL

    Proprietary Names

    Disposable silicone Foley catheter All Silicone Foley Catheter with Temperature Sensor Latex Foley Catheter

    Establishment Types

    Export Device to the United States But Perform No Other Operation on Device