BEUDAMED
    FDA Registration Active 🇮🇱 Israel

    ALPHA OMEGA ENGINEERING LTD.

    Reg #: 9615126 · FEI: 3001610756 · Expires 2026
    View on FDA
    Products
    7
    Proprietary Names
    53
    Establishment Types
    3
    Classifications
    7

    Registration Details

    Registration Name
    ALPHA OMEGA ENGINEERING LTD.
    Registration Number
    9615126
    FEI Number
    3001610756
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Hamerkava St. 6, Tsiporit Industrial Zone
    City
    Nof HaGalil Northern
    Country
    IL

    Regulatory Submissions

    510(k) Number
    K120098

    Owner / Operator

    Firm Name
    ALPHA OMEGA ENGINEERING LTD.
    Operator Number
    9039414
    Address
    Hamerkava st.6, Tsiporit Industrial Zone
    City
    Nof HaGalil (Nazareth Illit)
    State
    Northern
    Postal Code
    1789062
    Country
    IL

    Products

    Device Name Product Code
    Electrode, Depth GZL
    Stimulator, Electrical, Evoked Response GWF
    Full-Montage Standard Electroencephalograph GWQ
    Electrode, Cortical GYC
    Electromyograph, Diagnostic IKN
    Medical Device Data System OUG
    Cannula, Surgical, General & Plastic Surgery GEA

    Proprietary Names

    Sterile Cannula Sterile NeuroProbe Sterile Electrode Cable MicroGuide Neuro Omega NeuroSmart NeuroSmart system Neuro Omega system NeuroFortis Neuro Omega Drive Headstage Neuro Omega MER Headstage Neuro Omega Drive Headstage Neuro Omega Autoclavable Drive Neuro Omega Autoclavable Drive Headstage Neuro Omega with Neuro Omega drive + 2 basic stimulation Slots Neuro Omega with Neuro Omega drive + 1 basic stimulation Slot Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot Neuro Omega EMG HeadBox Kit Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots Neuro Omega ECOG HeadBox Kit Sterile LeadConfirm A Cable Sterile LeadConfirm B Cable Sterile LeadConfirm M Adaptor Sterile LeadConfirm A Adaptor Sterile LeadConfirm M Cable NeuroNav NeuroSmart NeuroFortis NeuroSmart Drive Headstage NeuroNav Drive Headstage NeuroSmart MER Headstage NeuroNav MER Headstage NeuroNav with Autoclavable Drive Headstage NeuroSmart Autoclavable Drive Headstage Kit NeuroNav Drive Headstage Kit NeuroNav with NeuroNav Drive NeuroSmart MER Headstage Kit NeuroSmart with AutoClavable Drive Headstage NeuroFortis NeuroSmart Drive Headstage Kit NeuroNav with MER Headstage NeuroNav MER Headstage Kit NeuroNav with NeuroFortis Drive NeuroSmart Autoclavable Drive Headstage NeuroSmart with NeuroFortis Drive NeuroProbe aCare SENS Cannula NeuroDrive Libenger RM frame Mechanical Set Kit NexFrame Mechanical Set Kit Starfix frame Mechanical Set Kit Libenger ZD frame Mechanical Set Kit CRW Non-XY frame Mechanical Set Kit Leksell Non-XY frame Mechanical Set Kit NexDrive Electrode Holder - Pack of 2

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device