HomeJapanEIKEN CHEMICAL CO., LTD.

EIKEN CHEMICAL CO., LTD.

Japan · Chiyoda-Ku
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Singapore, Australia, Israel, Russia — 7 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
2listed device types
Class I 0Class II 2Class III 0
plus 11 registration records and 4 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 3Class II 2
6 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
4device registrations
CLASS B 1CLASS C 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
8active ARTG entries
IVD Class 1 6IVD Class 2 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 2Class 2b 3
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 States11 registration records, 4 510(k), 0 PMA, 1 excluded
Brazil5 confirmed, 0 excluded
Manufacturer names merged into this page: Eiken Chemical Co., Ltd. Nasu Plant · EIKEN CHEMICAL CO., LTD. · EIKEN CHEMICAL CO., LTD. NOGI PLANT · EIKEN CHEMICAL CO. LTD. (NASU PLANT)

Company information

Country
Japan
City
Chiyoda-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.

Business registration

Legal name
EIKEN CHEMICAL CO.,LTD.
Corporate Number
2010501028231
Registration status
Active
Registered capital
JPY 6,897,000,000

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

FDA 510(k) clearances by year

11985 · K853391
11986 · K864342
12015 · K143325
12020 · K191147

FDA listed device types

Automated Occult Blood Analyzer 1Reagent, Occult Blood 1

Registration details (sample)

MarketIdentifierNameClass / date
USK191147OC-Auto SENSOR io iFOB Test2020-01-02
USK143325OC-Light S FIT2015-08-20
USK864342MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX1986-12-01
BR10322610036Wash Concentrate OC-Auto Micro 80 iFOB TestClass I
BR10322610044OC-Auto® Sampling BottlesClass I
BR10322610052Buffer OC-Auto Micro 80 iFOBClass I

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