HomeJapanNIHON SEIMITSU SOKKI CO., LTD.

NIHON SEIMITSU SOKKI CO., LTD.

Japan · Shibukawa
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, 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
4listed device types
Class I 2Class II 2Class III 0
plus 4 registration records and 21 510(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
0active device licences
7 including historic records
TWTaiwanTFDA
10valid device licences
Class II 10
SGSingaporeHSA SMDR
7device registrations
CLASS B 7
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
8active registrations
Class 1 2Class 2a 6
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 States4 registration records, 21 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: NIHON SEIMITSU SOKKI CO., LTD.

Company information

Country
Japan
City
Shibukawa

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

41985
11988
11995
21999
12000
12001
12003
12004
12005
12006
12007
22008
12010
32012

FDA listed device types

Bulb, Inflation, For Endoscope 1Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) 1Urinometer, Mechanical 1System, Measurement, Blood-Pressure, Non-Invasive 1

Registration details (sample)

MarketIdentifierNameClass / date
USK112620DISITAL BLOOD PRESSURE MONITOR2012-08-02
USK112690BLOOD PRESSURE MONITOR2012-02-24
USK112691BLOOD PRESSURE MONITOR2012-02-24
BR80070219006ESFIGMOMANÔMETRO NISSEI HT-1500Class II
BR80070219018ESFIGMOMANÔMETRO PALM MDClass II

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