HomeJapanDENKA CO., LTD.

DENKA CO., LTD.

Japan · Gosen-Shi Niigata
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Taiwan, South Korea, Australia, Hong Kong, Israel — 6 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
18listed device types
Class I 6Class II 12Class III 0
plus 17 registration records and 0 510(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
62valid device licences
Class I 21Class II 40Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
7GMP quality-system certificates
IVD import 7
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 2 2
HKHong KongMDACS
1valid listings
IVD B 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 States17 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil0 confirmed, 2 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: DENKA CO., LTD.

Company information

Country
Japan
City
Gosen-Shi Niigata

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.

Business registration

Legal name
Denka Company Limited
Corporate Number
3010001008757
Registration status
Active
Registered capital
JPY 36,998,000,000

Business registration data from EDINET (Japan FSA), retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 18
System, Test, Beta-2-Microglobulin Immunological 1Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total) 1Calibrator, Secondary 1Ferritin, Antigen, Antiserum, Control 1Calibrator, Primary 1System, Test, Rheumatoid Factor 1C-Reactive Protein, Antigen, Antiserum, And Control 1Calibrator, Multi-Analyte Mixture 1

Similar companies

A2MediteX Corporation
Japan · markets 0
ACTIF CORPORATION CO., LTD
Japan · markets 0
Actment Co., Ltd
Japan · markets 0
Advanced Photonics, Inc.
Japan · markets 1
Advantec Toyo Kaisha, Ltd.
Japan · markets 0
ALCARE Co.,Ltd
Japan · markets 4
Is this your company? Claim the page, add information or report a data error.Claim / report an error →