HomeCanadaKent Imaging, Inc.

Kent Imaging, Inc.

Canada · Calgary
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Australia, Hong Kong, Israel — 5 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
4listed device types
Class I 1Class II 3Class III 0
plus 6 registration records and 5 510(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
0active device licences
1 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
1registrations
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 States6 registration records, 5 510(k), 0 PMA, 14 excluded
Brazil0 confirmed, 1 excluded
Saudi Arabia0 confirmed, 2 excluded
Manufacturer names merged into this page: Kent Imaging Inc · KENT IMAGING, INC.

Company information

Country
Canada
City
Calgary

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

12012 · K113507
12017 · K163070
12020 · K201976
12024 · K240601
12025 · K242669

FDA listed device types

Oximeter, Tissue Saturation 1Drape, Surgical, Exempt 1Autofluorescence Imaging Adjunct Tool For Wounds 1Tape, Camera, Surgical 1

Registration details (sample)

MarketIdentifierNameClass / date
USK242669SnapshotGLO (KB100)2025-03-26
USK240601SnapshotNIR model KD2052024-04-02
USK201976SnapshotNIR2020-11-10

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