BEUDAMED
    FDA Registration Active 🇺🇸 United States

    URO-1, INC.

    Reg #: 3027269340 · FEI: 3027269340 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    URO-1, INC.
    Registration Number
    3027269340
    FEI Number
    3027269340
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3703 Alliance Drive, Suite A
    City
    Greensboro
    State
    NC
    ZIP
    27407
    Country
    US

    Regulatory Submissions

    510(k) Number
    K230646

    Owner / Operator

    Firm Name
    Uro1 Medical, Inc.
    Operator Number
    10087857
    Address
    3703 Alliance Drive, Suite A
    City
    Greensboro
    State
    NC
    Postal Code
    27407
    Country
    US
    Correspondent
    Thomas Lawson

    Products

    Device Name Product Code
    Instrument, Biopsy KNW
    Gastroenterology-Urology Accessories To A Biopsy Instrument QFZ
    Endoscopic Injection Needle, Gastroenterology-Urology FBK

    Proprietary Names

    SUREcore Prime coreCARE Repris SUREcore Plus SUREcore needle

    Establishment Types

    Manufacture Medical Device