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Alpha Omega Engineering Corp.

US

Last updated May 24, 2026

Part of Alpha Omega Engineering Ltd

Information

Country
US
Address
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Website
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LinkedIn
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Facebook
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Email
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Phone
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PRRC Contact
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EUDAMED SRN
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FDA FEI Number
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DUNS Number
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Catalogue (356)

Page 7 of 8
DeviceModel / ReferenceRegistriesClassStatus
NeuroNav NeuroNav
FDA UDI
Class IIActive
NeuroProbe MF-Shielded
FDA UDI
Class IIActive
NeuroSmart Main Unit NeuroSmart Main Unit
FDA UDI
Class IIActive
NeuroProbe MF-Shielded
FDA UDI
Class IIActive
NeuroSmart MER Headstage NeuroSmart MER Headstage
FDA UDI
Class IIActive
NeuroProbe Shielded
FDA UDI
Class IIActive
Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots Neuro Omega with Neuro Omega Drive Headstage + 2 basic stimulation Slots
FDA UDI
Class IIActive
NeuroOmega Autoclavable Drive
FDA UDI
Class IIActive
Power cable Plug Type L-5.5mm
FDA UDI
Class IIActive
Leibinger ZD frame Mechanical Set KIT Long Bengun
FDA UDI
Class IIActive
Neuro Omega NeuroFortis Drive Headstage Neuro Omega NeuroFortis Drive Headstage
FDA UDI
Class IIActive
Sterile electrode's cable Sterile electrode's cable
FDA UDI
Class IIActive
Tube Lead Insertion
FDA UDI
Class IIActive
LeadConfirm Sterile NeuroSmart/NeuroNav MER LeadConfirm M Cable
FDA UDI
Class IIActive
Sterile electrode's cable Sterile electrode's cable
FDA UDI
Class IIActive
Neuro Omega Input Cable 4 channels MER only
FDA UDI
Class IIActive
NeuroNav with MER Headstage NeuroNav with MER Headstage
FDA UDI
Class IIActive
Cannula Standard
FDA UDI
Class IIActive
Sterile LeadConfirm Sterile LeadConfirm
FDA UDI
Class IIActive
NeuroProbe Non-shielded
FDA UDI
Class IIActive
Neuro Omega EEG Recording Kit Neuro Omega EEG Recording Kit
FDA UDI
Class IIActive
NeuroProbe MF-Shielded
FDA UDI
Class IIActive
Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot Neuro Omega with Neuro Omega Drive Headstage + 1 basic stimulation Slot
FDA UDI
Class IIActive
Cannula Tapered
FDA UDI
Class IIActive
NeuroProbe Shielded
FDA UDI
Class IIActive
NeuroProbe Non-shielded
FDA UDI
Class IIActive
Neuro Omega EMG HeadBox Kit Neuro Omega EMG HeadBox Kit
FDA UDI
Class IIActive
Sterile electrode's cable Sterile electrode's cable
FDA UDI
Class IIActive
NeuroProbe Shielded
FDA UDI
Class IIActive
LeadConfirm Sterile NeuroSmart/NeuroNav LeadConfirm M Adaptor
FDA UDI
Class IIActive
NeuroNav Pelican Case NeuroNav Pelican Case
FDA UDI
Class IIActive
NeuroNav Input Cable 4 channels MER only
FDA UDI
Class IIActive
NeuroNav Drive NeuroNav Drive
FDA UDI
Class IIActive
NeuroOmega Autoclavable Drive-Head Stage
FDA UDI
Class IIActive
NeuroNav MER Headstage MER Headstage
FDA UDI
Class IIActive
Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot Neuro Omega with NeuroFortis drive + 1 basic stimulation Slot
FDA UDI
N/AActive
NexDrive Electrode Holder NexDrive Electrode Holder - Pack of 2
FDA UDI
Class IIActive
Insertion Tube Set 40mm above
FDA UDI
Class IIActive
Power cable Plug Type H
FDA UDI
Class IIActive
Ground Kit NN Ground Kit NN
FDA UDI
Class IIActive
NeuroNav Input Cable 1 channel MER only
FDA UDI
Class IIActive
Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots Neuro Omega with NeuroFortis drive + 2 basic stimulation Slots
FDA UDI
N/AActive
NeuroSmart with AutoClavable Drive Headstage Rev. 5
FDA UDI
Class IIActive
NeuroNav Headstage cable - Autoclavable Headstage cable - Autoclavable
FDA UDI
Class IIActive
NeuroNav with NeuroNav Drive NeuroNav with NeuroNav Drive
FDA UDI
Class IIActive
NeuroNav Input Cable 5 channels
FDA UDI
Class IIActive
Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots Neuro Omega with NeuroFortis Drive Headstage + 2 basic stimulation Slots
FDA UDI
Class IIActive
NeuroSmart with NeuroFortis Drive NeuroSmart with NeuroFortis Drive
FDA UDI
Class IIActive
Power cable Plug Type G
FDA UDI
Class IIActive
Power cable Plug Type I
FDA UDI
Class IIActive

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Sep 4, 2018Z-1216-2019—terminated

If cables are improperly connected, current may reach high charge density, causing tissue harm.