Alpha Omega Engineering Ltd
Active in EUDAMEDIsraelfrom SRN EUDAMED FDA SRN IL-MF-000025214
Alpha Omega Engineering Ltd is a medical device manufacturer based in Israel, with 171 devices listed in EUDAMED, FDA GUDID and FDA 510(k) (EU Class I, III and IIb; FDA Class II) as of 14 Nov 2026.
- Devices
- 171
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- EUDAMED 164
- FDA GUDID 131
- FDA 510(k) 7
- Device classes
- EU Class I 99
- EU Class III 59
- FDA Class II 7
- EU Class IIb 6
- Top EMDN categories
- Sites and related companies
- Alpha Omega GmbH authorised representative
- Identifiers
- EUDAMED SRN IL-MF-000025214
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA establishment
- Authorised rep.
- Alpha Omega GmbHDE
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.
Catalogue
Search and filter all 171 devicesShowing 1-50 of 171
Company details
- EUDAMED SRN
- IL-MF-000025214
- EU VAT number
- 511904245
- EUDAMED status
- Active
- EUDAMED registered name
- Alpha Omega Engineering Ltd
- EUDAMED abbreviated name
- AOE
- Registered address
- 6, Hamerkava, 1789062, Nof HaGalil (Nazareth Illit), Israel
- Website
- alphaomega-eng.com
- linkedin.com/company/alpha-omega
- Phone
- +972 4 6563327 ext. 143
- PRRC contact
- Efrat Shamgar
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 16 Nov 2028
DQS Medizinprodukte GmbH 0297 1 certificate
- 1000178902 Active
Technical documentation EU MDR
- Issued
- 1 Aug 2024
- Expires
- 16 Nov 2028
- Reason
- Change approved
FDA establishments
- Alpha Omega Engineering Corp. US
From the company website
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.
Frequently asked questions
How many devices does Alpha Omega Engineering Ltd have in the registry?
The registry currently lists 171 devices for Alpha Omega Engineering Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Alpha Omega Engineering Ltd's devices?
Among its 50 most recently registered devices, Alpha Omega Engineering Ltd has devices listed in EUDAMED (43 devices), FDA 510(k) (7 devices) and FDA GUDID (32 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Alpha Omega Engineering Ltd's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Alpha Omega Engineering Ltd's devices are Class I, Class IIb, Class II and Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Alpha Omega Engineering Ltd?
EUDAMED lists 1 certificate for Alpha Omega Engineering Ltd (technical documentation) under MDR. The most recent was issued on 1 Aug 2024.
What are the newest devices from Alpha Omega Engineering Ltd in the registry?
The most recently registered devices listed for Alpha Omega Engineering Ltd include Neuro Omega Pro with 2 NeuroFortis Drive Headstage + 1 basic stimulation Slots, Neuro Omega with NeuroFortis Drive Headstage + 1 basic stimulation Slot, NeuroFortis Neuro Omega Drive Headstage KIT and Neuro Omega Pro with 2 AutoClavable Drive Headstages.
Which FDA establishments are linked to Alpha Omega Engineering Ltd?
1 FDA establishment is linked to Alpha Omega Engineering Ltd in the registry; they are listed on the company page.