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Alpha Omega Engineering Ltd

Israel IL-MF-000025214 Last updated 21 Oct 2026

Devices
171
Registries
EUDAMEDFDA 510(k)GUDIDFDA
FDA recalls
0

Catalogue171

Page 1 of 4

Showing 1-50 of 171

EUDAMED certificates2

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (2)

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

Authorised representatives

Notified bodies

  • Notified body 0297

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • 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.

From the manufacturer's own website. Source

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.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

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.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Israel
Address
6, Hamerkava , Nof HaGalil (Nazareth Illit), Israel
Phone
+972 4 6563327 ext. 143
PRRC contact
Efrat Shamgar
EUDAMED SRN
IL-MF-000025214