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Omega Medical Diagnostics

USA · Mchenry
✓ 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
7510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
10 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 States0 registration records, 7 510(k), 0 PMA, 29 excluded
Brazil2 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada1 confirmed, 3 excluded
Manufacturer names merged into this page: OMEGA DIAGNOSTICS GROUP PLC · OMEGA DIAGNOSTICS LTD. · OMEGA DIAGNOSTICS
Same-named companies — This database also contains companies with near-identical names: OMEGA DIAGNOSTICS GROUP PLC. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mchenry

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

51983 · K832182
11987 · K873010
11988 · K882949

Registration details (sample)

MarketIdentifierNameClass / date
USK882949TYMPANIC TEMPERATURE SCANNER1988-11-01
USK873010SURFACE TEMPERATURE SCANNER1987-11-17
USK832182LYSING REAGENT1983-08-12
BR80115310141Food Detective™Class II
BR10350840181FoodPrint Microarray 200 + Food IgGClass II
CA63985INTRINSIC FACTOR IGG ELISA KITClass II

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