HomeJapanKEISEI MEDICAL INDUSTRIAL CO., LTD.

KEISEI MEDICAL INDUSTRIAL CO., LTD.

Japan · Bunkyo-Ku T?Ky?
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Taiwan, Singapore, Russia — 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
6listed device types
Class I 3Class II 3Class III 0
plus 6 registration records and 4 510(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
5valid device licences
Class I 4Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
1active registrations
Class 2a 1
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 States6 registration records, 4 510(k), 0 PMA, 2 excluded
Manufacturer names merged into this page: KEISEI MEDICAL INDUSTRIAL CO., LTD.

Company information

Country
Japan
City
Bunkyo-Ku T?Ky?

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

41986 · K863211

FDA listed device types

Instrument, Surgical, Disposable 1Microscope, Surgical 1Dermatome 1Suture, Nonabsorbable, Synthetic, Polyamide 1Bed, Air Fluidized 1Clamp, Vascular 1

Registration details (sample)

MarketIdentifierNameClass / date
USK863211KEISEI SURGICAL BLADES (STERILE & NON-STERILE)1986-09-02
USK863212KEISEI HANDLES FOR SURGICAL BLADES1986-09-02
USK863213KEISEI SCALPEL (STERILE AND NON-STERILE)1986-09-02

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