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Medical Soft, Inc.

USA · Ellicott City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 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
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 1Class II 5
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered 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
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, 1 510(k), 0 PMA, 19 excluded
Brazil6 confirmed, 2 excluded
Saudi Arabia1 confirmed, 1 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: SOFT MEDICAL AESTHETICS · SOFT MEDICAL TREATMENT HEALTH CARE PRODUCTS CO., LTD. · SOFT LOGIC, INC. d/b/a TECFEN MEDICAL
Same-named companies — This database also contains companies with near-identical names: SOFT MEDICAL AESTHETICS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Ellicott City

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

11995 · K942490

Registration details (sample)

MarketIdentifierNameClass / date
USK942490BABE COMPUTER POGRAM FOR OBSTETRIC ULTRASOUND1995-02-15
BR80451960194SoftFil® essencia microcânulaClass II
BR80451960195SoftFil® EasyGuide microcânulaClass II
BR80451960139SOFTFILClass II
SAME0000006854SFDAA00005DUAL EYE SHIELD—

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