HomeUSACanon, Inc. – Medical Equipment Group

Canon, Inc. – Medical Equipment Group

USA · Richardson
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, South Korea, Israel — 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
12510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class I 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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 States0 registration records, 12 510(k), 0 PMA, 16 excluded
Brazil2 confirmed, 6 excluded
Saudi Arabia0 confirmed, 2 excluded
Canada0 confirmed, 7 excluded
Manufacturer names merged into this page: CANON INC MEDICAL EQUIPAMENT GROUP

Company information

Country
USA
City
Richardson

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

22010
42011 · K111710
32012 · K121303
12013 · K123208
12017 · K162909
12018 · K173689

Registration details (sample)

MarketIdentifierNameClass / date
USK173689Ophthalmic Software Platform RX2018-02-23
USK162909CSX-30 Flat Panel Detector2017-01-27
USK123208DIGITAL RETINAL CAMERA2013-03-19
BR80497819004AUTO TONÔMETRO TX-FClass I
BR80497819005AUTO REFRATÔMETRO/CERATÔMETRO RK-F1Class I

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