HomeJapanTOKAI MEDICAL PRODUCTS, INC.

TOKAI MEDICAL PRODUCTS, INC.

Japan · Toki-City Gifu
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 8 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
1listed device types
Class I 0Class II 1Class III 0
plus 1 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
7registered devices
Class II 7
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
2valid device licences
Class II 2
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
3GMP quality-system certificates
Import 3
AUAustraliaTGA ARTG
1active ARTG entries
IIa 1
HKHong KongMDACS
3valid listings
Class II 2Class IV 1
ILIsraelAMAR
2registrations
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 States1 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil7 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Manufacturer names merged into this page: TOKAI MEDICAL PRODUCTS · TOKAI MEDICAL PRODUCTS, INC.

Company information

Country
Japan
City
Toki-City Gifu

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 listed device types

System, Balloon, Intra-Aortic And Control 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80202910097MICROCATETER TOKAI - CARNELIAN (PONTA ÂNGULO DUPLO)Class II
BR80202910098MICROCATETER TOKAI - CARNELIAN (PONTA COBRA)Class II
BR80202910100MICROCATETER TOKAI - CARNELIAN SUPPORTClass II

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