BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    BIS™ Advance Monitoring System

    Reg #: 8044004 · FEI: 3001227743 · Expires 2025
    View on FDA
    Products
    4
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    ORIDION MEDICAL 1987 LTD.
    Registration Number
    8044004
    FEI Number
    3001227743
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7 HAMARPE ST. P.O. BOX 45025
    City
    JERUSALEM
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K230693

    Owner / Operator

    Firm Name
    Covidien llc
    Operator Number
    1282497
    Address
    15 HAMPSHIRE STREET, --
    City
    Mansfield
    State
    MA
    Postal Code
    02048
    Country
    US

    US Agent

    Business Name
    Covidien
    Contact Name
    Kae Miller
    Address
    6135 Gunbarrel Ave
    City
    Boulder
    State
    CO
    ZIP
    80301
    Country
    US
    Email
    [email protected]
    Phone
    303 8768859

    Products

    Device Name Product Code
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Index-Generating Electroencephalograph Software OLW
    Burst Suppression Detection Software For Electroencephalograph ORT
    Reduced- Montage Standard Electroencephalograph OMC

    Proprietary Names

    BIS™ Advance Monitoring System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility