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Home›USA›KOVEN TECHNOLOGY, INC.

KOVEN TECHNOLOGY, INC.

USA · St. Louis
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Australia — 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
9listed device types
Class I 2Class II 7Class III 0
plus 15 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
5active device licences
Class III 4Class IV 1
18 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 States15 registration records, 18 510(k), 0 PMA, 1 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: KOVEN TECHNOLOGY, INC. · KOVEN TECHNOLOGY CANADA INC.
Same-named companies — This database also contains companies with near-identical names: KOVEN TECHNOLOGY CANADA INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
St. Louis

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

21994
11995
31996
11997
11998
22002
12003
12004
12005
12008
12014
12015
12016
12021

FDA listed device types

showing 8 of 9
Transducer, Ultrasonic 1Transducer, Ultrasonic, Diagnostic 1Flowmeter, Blood, Cardiovascular 1System, Imaging, Pulsed Echo, Ultrasonic 1System, Imaging, Pulsed Doppler, Ultrasonic 1Blood Pressure Cuff 1Monitor, Ultrasonic, Nonfetal 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK201114Bidop 72021-01-05
USK153762Smartdop XT62016-05-25
USK143332Fast Sphyg by Koven2015-04-14
CA63305SMARTDOP 20EXClass III
CA63324SMARTDOP 50EXClass III
CA63760ECHO SOUNDER ES-101EXClass III

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