BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BRIGHT URO, INC.

    Reg #: 3029753827 · FEI: 3029753827 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    0
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    BRIGHT URO, INC.
    Registration Number
    3029753827
    FEI Number
    3029753827
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    3 Goddard
    City
    Irvine
    State
    CA
    ZIP
    92618
    Country
    US

    Regulatory Submissions

    510(k) Number
    K243052

    Owner / Operator

    Firm Name
    Bright Uro, Inc.
    Operator Number
    10093586
    Address
    3 Goddard
    City
    Irvine
    State
    CA
    Postal Code
    92618
    Country
    US
    Correspondent
    Suranjan Roychowdhury

    Products

    Device Name Product Code
    Cystometer, Electrical Recording EXQ
    Uroflowmeter EXY

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device