BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Optilume BPH Catheter System

    Reg #: 3015228875 · FEI: 3015228875 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    UROTRONIC INC
    Registration Number
    3015228875
    FEI Number
    3015228875
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2495 Xenium Lane North
    City
    Plymouth
    State
    MN
    ZIP
    55441
    Country
    US

    Regulatory Submissions

    PMA Number
    P220029

    Owner / Operator

    Firm Name
    Urotronic Inc
    Operator Number
    10063084
    Address
    2495 Xenium Lane North
    City
    Plymouth
    State
    MN
    Postal Code
    55441
    Country
    US
    Correspondent
    Alex Zuniga

    Products

    Device Name Product Code
    Drug Coated Prostatic Dilation Catheter For Benign Prostatic Hyperplasia QXB

    Proprietary Names

    Optilume BPH Catheter System

    Establishment Types

    Manufacture Medical Device