HomeCanadaRAMSOFT, INC.

RAMSOFT, INC.

Canada · Toronto
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 6 510(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
0active device licences
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
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 States3 registration records, 6 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: RAMSOFT, INC. · RAMSOFT INC.

Company information

Country
Canada
City
Toronto

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

11994 · K942917
11998 · K982563
12003 · K031562
12005 · K052460
12014 · K141881
12022 · K222476

FDA listed device types

System, Image Processing, Radiological 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222476OmegaAI Image Viewer2022-11-17
USK141881RAPIDRESULTS2014-10-31
USK052460POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE2005-09-21
BR81464750189OmegaAI Image ViewerClass II
BR81464750047PowerServer™Class II

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