HomeIsraelAlpha Omega Engineering , Ltd.

Alpha Omega Engineering , Ltd.

Israel · Nazareth Illit
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
9listed device types
Class I 2Class II 7Class III 0
plus 18 registration records and 23 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 3Class II 1
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
6 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
1device registrations
CLASS D 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
6active ARTG entries
Class I 1Class III 2IIb 2Class Is (sterile) 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
2active registrations
Class 2b 2
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States18 registration records, 23 510(k), 0 PMA, 24 excluded
Brazil4 confirmed, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 4 excluded
Manufacturer names merged into this page: ALPHA-OMEGA SERVICES, INC. · ALPHA OMEGA ENGINEERING LTD. · OMEGA Engineering, Inc.
Same-named companies — This database also contains companies with near-identical names: Alpha Omega , Ltd., ALPHA-OMEGA SERVICES, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Israel
City
Nazareth Illit

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11981
11997
32000
12002
12005
12006
52007
12011
12012
12013
12017
12018
12020
12022
22024
12025

FDA listed device types

showing 8 of 9
System, Applicator, Radionuclide, Remote-Controlled 1Stimulator, Electrical, Evoked Response 1Electrode, Cortical 1Electromyograph, Diagnostic 1Electrode, Depth 1Full-Montage Standard Electroencephalograph 1Source, Brachytherapy, Radionuclide 1Medical Device Data System 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250601Neuro Omega System; NeuroSmart System2025-03-30
USK233628AOS Interstitial Templates, Needles, and Accessories2024-07-10
USK233626AOS Marker Seeds (SMG0242-025)2024-07-02
BR81869080016Acessórios Mecânicos Alpha OmegaClass I
BR81869080011Cânula estérilClass I
BR81869080015aCare SENSClass II

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