BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    UroGen Urinary Catheter

    Reg #: 3013024191 · FEI: 3013024191 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    UROGEN PHARMA LTD.
    Registration Number
    3013024191
    FEI Number
    3013024191
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    9 Ha'Ta'asiya Street
    City
    Ra'anana Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K211032

    Owner / Operator

    Firm Name
    Urogen Pharma Ltd.
    Operator Number
    10055966
    Address
    400 Alexander Park Drive
    City
    Princeton
    State
    NJ
    Postal Code
    08540
    Country
    US
    Correspondent
    James Ottinger

    US Agent

    Business Name
    Urogen Pharma Inc.
    Contact Name
    James Ottinger
    Address
    400 Alexander Park Drive, 4th Floor
    City
    Princeton
    State
    NJ
    ZIP
    08540
    Country
    US
    Email
    [email protected]
    Phone
    610 7451230

    Products

    Device Name Product Code
    Catheter, Coude EZC
    Catheter, Urological KOD

    Proprietary Names

    UroGen Urinary Catheter

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility