BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ORSENSE LTD

    Reg #: 3007358963 · FEI: 3007358963 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    ORSENSE LTD
    Registration Number
    3007358963
    FEI Number
    3007358963
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6 Ha'Nechoshet Street
    City
    Tel Aviv Yafo Central
    Country
    IL

    Regulatory Submissions

    510(k) Number
    BK190322

    Owner / Operator

    Firm Name
    OrSense
    Operator Number
    10032332
    Address
    6 Ha'Nechoshet Street
    City
    Tel Aviv Yafo
    State
    Central
    Postal Code
    6971070
    Country
    IL
    Correspondent
    Aharon Weinstein

    US Agent

    Business Name
    OrSense US, LLC
    Contact Name
    Charles Neff
    Address
    10900 World Trade Blvd, Suite 205
    City
    Raleigh
    State
    NC
    ZIP
    27617
    Country
    US
    Email
    [email protected]
    Phone
    919 6964267

    Products

    Device Name Product Code
    Hemoglobin For Donor Testing QGU
    Oximeter DQA
    Oximeter To Measure Hemoglobin GLY

    Proprietary Names

    NBM-200

    Establishment Types

    Manufacture Medical Device