BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Luminelle DTx Hysteroscopy System

    Reg #: 3014834623 · FEI: 3014834623 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    4
    Classifications
    2

    Registration Details

    Registration Name
    UVision 360, Inc.
    Registration Number
    3014834623
    FEI Number
    3014834623
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    158 Wind Chime Court, Suite #201
    City
    Raleigh
    State
    NC
    ZIP
    27615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181909

    Owner / Operator

    Firm Name
    Caldera Medical
    Operator Number
    10028052
    Address
    4360 Park Terrace Drive
    City
    Westlake Village
    State
    CA
    Postal Code
    91361
    Country
    US
    Correspondent
    Vicki Gail

    Products

    Device Name Product Code
    Cystoscope And Accessories, Flexible/Rigid FAJ
    Hysteroscope (And Accessories) HIH

    Proprietary Names

    Luminelle DTx Hysteroscopy System

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility Remanufacture Medical Device