Alpha Omega Engineering Ltd
Israel IL-MF-000025214 Last updated 21 Oct 2026
- Devices
- 171
- Registries
- EUDAMEDFDA 510(k)GUDIDFDA
- FDA recalls
- 0
Catalogue
Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot Ref NOW-1NB100-00
NeuroFortis Neuro Omega Drive Headstage KIT Ref 750-020070-00
Neuro Omega Pro with 2 AutoClavable Drive Headstages Ref NOW-2A0000-00
Neuro Omega Pro with 2 NeuroFortis Drive Headstages Ref NOW-2N0000-00
Neuroprobes Ref K052527
Micromar Bengun Ref 352-001039-00
Sterile electrode's cable Ref STR-000664-21
Sterile electrode's cable Ref STR-000642-55
MicroMar Non-XY frame Mechanical Set KIT Ref 700-020330-00
Sterile electrode's cable Ref STR-000526-11
Sterile neuroprobe Ref STR-901079-00
Sterile LeadConfirm Ref STR-000041-00
Sterile cannula Ref STR-000087-31
Sterile LeadConfirm Ref STR-S00041-00
Sterile LeadConfirm Ref STR-000082-00
Sterile neuroprobe Ref STR-001124-00
Bracket ZD Leibinger Ref 700-000847-00
Sterile electrode's cable Ref STR-000664-00
Sterile neuroprobe Ref STR-009024-00
Sterile LeadConfirm Ref STR-000055-00
Frame adapter thumb screw Ref 700-001330-00
Sterile LeadConfirm Ref STR-000083-00
αCare SENS Ref ACS-000000-00
Sterile neuroprobe Ref STR-007080-00
Ruler and DBs holder thumb screw Ref 344-001110-00
Sterile electrode's cable Ref STR-000642-22
Sterile electrode's cable Ref STR-000666-33
CRW Dual X/Y Frame Adapter Ref 341-001803-00
Leibinger RM Bracket Ref 700-000032-00
STarFix Frame Fixed Adapter T50 Ref 700-001997-00
Sterile cannula Ref STR-000021-00
Universal LeadConfirm cable holder silicone sleeve - Pack of 5 Ref 341-011308-05
Mechanical Accessories Sterilization Tray Ref 366-000022-22
Sterile neuroprobe Ref STR-222291-00
Sterile LeadConfirm Ref STR-000056-00
Leibinger ZD frame Mechanical Set KIT Ref 700-020847-00
Neuro Omega System Ref K123796
Neuro Omega System; NeuroSmart System Ref K250601
Neuro Omega System, NeuroSmart System Ref K220553
Sterile Disposables For Mer Ref K120098
NeuroNav System, NeuroSmart System Ref K172042
Neuro Omega System Ref K171581
Sterile neuroprobe Ref STR-AP9080-00
Sterile LeadConfirm Ref STR-000072-00
Sterile neuroprobe Ref STR-009023-00
Sterile electrode's cable Ref STR-000666-11
Headstage Sterilization Tray Ref 366-000122-22
Universal DBS holder silicone sleeve - Pack of 5 Ref 341-011305-05
Showing 1-50 of 171
EUDAMED certificates
Notified body 0297 2 certificates
- 1000178902 Supplemented
Technical documentation EU MDR
- Issued
- 1 Aug 2024
- Expires
- 16 Nov 2028
- Reason
- Change approved
- 1000324069 Supplemented
Quality management system EU MDR
- Issued
- 30 Jul 2026
- Expires
- 5 Apr 2028
- Reason
- Change approved
Related companies
Authorised representatives
Notified bodies
- Notified body 0297
FDA establishments
- Alpha Omega Engineering Corp. US
About
Alpha Omega develops systems, softwares and solutions to provide the high-quality, reliable data that drives pioneering neuroscience research & functional neurology and neurosurgery. The accuracy, precision, repeatability and overall dependability of these systems are no accident; working with the best engineers and collaborating with the best professionals leads to these results. We are proud of our customer satisfaction and continue to aim to bring the best solutions that will exceed their expectations.
What Alpha Omega Engineering Ltd makes
Alpha Omega Engineering Ltd manufactures neuroscience research tools, including neurostimulation systems like the Neuro Omega Pro with autoclavable drive headstages and multiple stimulation slots, as well as sterile neuroprobes, cannulae, and electrode cables. Their product line also includes mechanical probe sets, such as the MicroMar Non-XY frame kit, and sterile LeadConfirm components for neural signal verification. These devices are designed for precision in experimental and clinical neuroscience applications, including functional neurology and neurosurgery.
The company’s devices span regulatory classifications including Class I, Class II, Class IIb, and Class III under global standards, with listings in the EU’s EUDAMED database and FDA’s 510(k) registry. The portfolio is based in Israel, adhering to applicable medical device regulations for research and clinical use.
Frequently asked questions
What does Alpha Omega Engineering Ltd manufacture?
Alpha Omega Engineering Ltd manufactures neuroscience research tools including neurostimulation systems like the Neuro Omega Pro, sterile neuroprobes, cannulae, electrode cables, mechanical probe sets like the MicroMar Non-XY frame kit, and sterile LeadConfirm components for neural signal verification.
Where is Alpha Omega Engineering Ltd based?
Alpha Omega Engineering Ltd is based in Israel, as indicated by the country code 'IL' in their device data.
Which regulatory registries list Alpha Omega's devices?
Alpha Omega's devices are listed in the EU's EUDAMED database and the FDA's 510(k) registry, as specified in their device data.
How are Alpha Omega's devices classified?
Alpha Omega's devices span multiple regulatory classifications including Class I, Class II, Class IIb, and Class III under global medical device standards, as indicated in their device data.
Information
- Country
- Israel
- Address
- 6, Hamerkava , Nof HaGalil (Nazareth Illit), Israel
- Website
- alphaomega-eng.com
- linkedin.com/company/alpha-omega
- [email protected]
- Phone
- +972 4 6563327 ext. 143
- PRRC contact
- Efrat Shamgar
- EUDAMED SRN
- IL-MF-000025214