BEUDAMED
    FDA Registration Active 🇺🇸 United States

    URETHROTECH INC.

    Reg #: 3016998661 · FEI: 3016998661 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

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    Registration Details

    Registration Name
    URETHROTECH INC.
    Registration Number
    3016998661
    FEI Number
    3016998661
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    111 N. Chestnut Street, Suite 104
    City
    Winston Salem
    State
    NC
    ZIP
    27101
    Country
    US

    Regulatory Submissions

    510(k) Number
    K190060

    Owner / Operator

    Firm Name
    Urethrotech Inc.
    Operator Number
    10075263
    Address
    111 N. Chestnut Street, Suite 104
    City
    Winston Salem
    State
    NC
    Postal Code
    27101
    Country
    US
    Correspondent
    Daniela Andrich

    Products

    Device Name Product Code
    Catheter, Retention Type, Balloon EZL

    Proprietary Names

    Urethral Catheterisation Device (UCD®)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198