HomeJapanSekisui Medical Co., Ltd.

Sekisui Medical Co., Ltd.

Japan · Chuo-Ku
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, South Korea — 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
12listed device types
Class I 6Class II 6Class III 0
plus 10 registration records and 1 510(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
TWTaiwanTFDA
1valid device licences
Class I 1
SGSingaporeHSA SMDR
13device registrations
CLASS B 7CLASS C 6
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
IVD import 3
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 States10 registration records, 1 510(k), 0 PMA, 4 excluded
Brazil0 confirmed, 4 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: SEKISUI MEDICAL CO., LTD. Tsukuba Plant · SEKISUI MEDICAL CO., LTD. Tokuyama Plant

Company information

Country
Japan
City
Chuo-Ku

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

12018 · K173202

FDA listed device types

showing 8 of 12
Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl 1System, Test, Low Density, Lipoprotein 1Instrumentation, High Pressure Liquid Chromatography 1Ldl & Vldl Precipitation, Hdl 1Lipase-Esterase, Enzymatic, Photometric, Lipase 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Hemoglobin A1c Test System 1Calibrator, Secondary 1

Registration details (sample)

MarketIdentifierNameClass / date
USK173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set2018-05-09

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