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Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center

Japan · Fukaya-Shi Saitama

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

38listed device types

Class I 4Class II 34Class III 0

plus 70 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 3Class II 6

10 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

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 States70 registration records, 0 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: NIHON KOHDEN TOMIOKA PRODUCTION CENTER · Nihon Kohden Tomioka Corporation · Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center · NIHON KOHDEN TOMIOKA CORPORATION · NIHON KOHDEN TOMIOKA CORPORATION. · NIHON KOHDEN TOMIOKA CORPORATION TOMIOKA PRODUCTION CENTER

Same-named companies — This database also contains companies with near-identical names: NIHON KOHDEN TOMIOKA CORPORATION., NIHON KOHDEN TOMIOKA PRODUCTION CENTER, NIHON KOHDEN TOMIOKA CORPORATION TOMIOKA PRODUCTION CENTER. Company name alone cannot separate their registrations, so the figures below may include either.

FDA listed device types

showing 8 of 38

System, Network And Communication, Physiological Monitors 1Detector And Alarm, Arrhythmia 1Amplifier And Signal Conditioner, Transducer Signal 1Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrode, Cortical 1Electromyograph, Diagnostic 1Automatic Event Detection Software For Full-Montage Electroencephalograph 1Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10263619008	ELETROENCEFALOGRAMA EEG-1250	Class II
BR	10263619007	SISTEMA DE POLISSONOGRAFIA PSG-1100	Class II
BR	10263610032	PASTA PARA ELETROENCEFALOGRAMA ELEFIX	Class I

Nihon Kohden Tomioka Corporation Nihon Kohden Kawamoto Production Center

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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