HomeJapanASAHI KASEI MEDICAL CO., LTD.

ASAHI KASEI MEDICAL CO., LTD.

Japan · Chiyoda-Ku
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, Hong Kong, Russia — 5 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
3listed device types
Class I 0Class II 0Class III 2unclassified 1
plus 5 registration records and 6 510(k), 17 PMA
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
9active device licences
Class III 9
10 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
Class III 1
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
7active registrations
Class 2a 2Class 2b 3Class 3 2
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 States5 registration records, 6 510(k), 17 PMA, 2 excluded
Canada9 confirmed, 1 excluded
Manufacturer names merged into this page: Asahi Kasei Medical MT Corp. Oita Works · ASAHI KASEI MEDICAL CO., LTD.
Same-named companies — This database also contains companies with near-identical names: Asahi Kasei Pharma Corporation, Asahi Medical Co., Ltd.. Company name alone cannot separate their registrations, so the figures below may include either.

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
Asahi Kasei Corporation
Corporate Number
5120001059606
Registration status
Active
Registered capital
JPY 103,389,000,000

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

12005 · K051187
12008 · K082515
12013 · K121409
12015 · K153344
22017 · K170147

FDA listed device types

Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma 1Lipoprotein, Low Density, Removal 1Apheresis For Focal Glomerulosclerosis In Adult And Pediatric Patients 1

Registration details (sample)

MarketIdentifierNameClass / date
USK170147Lucica Glycated Albumin-L2017-10-12
USK162248Asahi ViE-U Series Dialyzer2017-05-03
USK153344Asahi REXEED-S Series Dialyzer2015-12-17
CA13378HEMOSORBA HEMOPERFUSION COLUMNClass III
CA10231HEMOFILTERS, PAN SERIESClass III
CA12910RHEOFILTER AR-2000 ASAHI PLASMA COMPONENT SEPARATORClass III

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