BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B`ORZE INC DIGITAL VIDEO COLPOSCOPE HD INTTELIO MODEL NO BZ-HDI-001

    Reg #: 3010395077 · FEI: 3010395077 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    B'ORZE INC
    Registration Number
    3010395077
    FEI Number
    3010395077
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    950 W Bannock, Suite 100
    City
    Boise
    State
    ID
    ZIP
    83702
    Country
    US

    Regulatory Submissions

    510(k) Number
    K122311

    Owner / Operator

    Firm Name
    B'Orze Inc USA
    Operator Number
    10046152
    Address
    950 W Bannock Suite 1100
    City
    Boise
    State
    ID
    Postal Code
    83702
    Country
    US
    Correspondent
    Rex Frazier

    Products

    Device Name Product Code
    Colposcope (And Colpomicroscope) HEX

    Proprietary Names

    B`ORZE INC DIGITAL VIDEO COLPOSCOPE HD INTTELIO MODEL NO BZ-HDI-001

    Establishment Types

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