HomeJapanKonica Medical and Graphic Corporation

Konica Medical and Graphic Corporation

Japan · Mie-Ken
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
40510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 40 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
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, 40 510(k), 0 PMA, 8 excluded
Brazil1 confirmed, 4 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: KONICA MINOLTA MEDICAL & GRAPHIC, INC

Company information

Country
Japan
City
Mie-Ken

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

11990
71993
11996
21997
11999
32002
12003
22004
62005
12006
22007
12008
12009
12010
32011
62012
12013

Registration details (sample)

MarketIdentifierNameClass / date
USK130936AERODR SYSTEM WITH P-312013-08-22
USK123499AEROPILOT2012-12-20
USK120752AERODR STITCHING SYSTEM2012-06-08
BR80210210004FILME LASER DRYPRO KONICA MINOLTAClass II

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