BEUDAMED
    FDA Registration Active 🇺🇸 United States

    B'ORZE INC

    Reg #: 3010395077 · FEI: 3010395077 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    4

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    Registration Details

    Registration Name
    B'ORZE INC
    Registration Number
    3010395077
    FEI Number
    3010395077
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    950 W Bannock, Suite 100
    City
    Boise
    State
    ID
    ZIP
    83702
    Country
    US

    Regulatory Submissions

    510(k) Number
    K123335

    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
    System, Monitoring, Perinatal HGM
    Transducer, Ultrasonic, Obstetric HGL
    Colposcope (And Colpomicroscope) HEX
    Monitor, Ultrasonic, Fetal KNG

    Proprietary Names

    B`ORZE FETAL MONITOR WL 15000 MODEL NO BZ - WL - 015 - 01 B`ORZE INC DIGITAL VIDEO COLPOSCOPE HD INTTELLIO MODEL NO BZ-HD1-001 B`ORZE INC USA FETAL MONITOR FM 700

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility