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OMEGA Engineering, Inc.

USA

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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

7listed device types

Class I 2Class II 5Class III 0

plus 13 registration records and 9 510(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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

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 States13 registration records, 9 510(k), 0 PMA, 28 excluded

Brazil4 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 4 excluded

Manufacturer names merged into this page: ALPHA OMEGA ENGINEERING LTD. · OMEGA Engineering, Inc.

FDA 510(k) clearances by year

11981

12006

12012

12013

12017

12018

12020

12022

12025

FDA listed device types

Stimulator, Electrical, Evoked Response 1Electrode, Cortical 1Electromyograph, Diagnostic 1Electrode, Depth 1Full-Montage Standard Electroencephalograph 1Medical Device Data System 1Cannula, Surgical, General & Plastic Surgery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250601	Neuro Omega System; NeuroSmart System	2025-03-30
US	K220553	Neuro Omega System, NeuroSmart System	2022-09-16
US	K191739	Sterile LeadConfirm	2020-01-02
BR	81869080016	Acessórios Mecânicos Alpha Omega	Class I
BR	81869080011	Cânula estéril	Class I
BR	81869080015	aCare SENS	Class II

OMEGA Engineering, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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