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Denka Seiken'S

Japan · Tokyo
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
10510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 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
2active device licences
Class II 2
4 including historic records
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, 10 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: DENKA SEIKEN CO. LTD · DENKA SEIKEN CO. LTD. NIIGATA FACTORY - JAPÃO PARA ROCHE DIAGNOSTICS GMBH · DENKA SEIKEN CO. LTD.
Same-named companies — This database also contains companies with near-identical names: Denka Seiken Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Japan
City
Tokyo

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

11998
12001
22002
22003
12004
12005
12006
12017

Registration details (sample)

MarketIdentifierNameClass / date
USK161679s LDL-EX SEIKEN2017-08-18
USK060359ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-102006-04-14
USK043264LDL-EX SEIKEN ASSAY KIT2005-01-26
BR10287410574ASLOT, Tina-Quant (a) antistreptolisina OClass II
BR80146501548Rheumatoid Factor CalibratorClass II
CA28331PARVO IGM-EIAClass II
CA28332PARVO IGG-EIAClass II

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