Home›USA›Nihon Kohden Digital Health Solutions, LLC.

Nihon Kohden Digital Health Solutions, LLC.

USA · Irvine

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel — 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

53listed device types

Class I 17Class II 36Class III 0

plus 343 registration records and 204 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

25registered devices

Class I 10Class II 15

52 including historic records

SASaudi ArabiaSFDA

52registered imported devices

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

CACanadaMDALL

32active device licences

Class II 12Class III 20

39 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States343 registration records, 204 510(k), 0 PMA

Brazil25 confirmed, 2 excluded

Saudi Arabia52 confirmed, 1 excluded

Canada32 confirmed, 0 excluded

Manufacturer names merged into this page: Nihon Kohden Corporation - Eastern Japan Logistics Center · NIHON KOHDEN TOMIOKA PRODUCTION CENTER · Nihon Kohden America Fulfillment Center · NIHON KOHDEN AMERICA, INC. · NIHON KOHDEN CORPORATION · Nihon Kohden Brasil Importação, Exportação e Comércio de Equipamentos Médicos LTDA

Same-named companies — This database also contains companies with near-identical names: Nihon Kohden Corporation, NIHON KOHDEN AMERICA, INC., Nihon Kohden Brasil Importação, Exportação e Comércio de Equipamentos Médicos LTDA. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22006

42007

72008

12009

32010

42011

42012

12013

32015

22016

52017

12018

22019

22020

32021

32022

22023

12024

32025

22026

FDA listed device types

showing 8 of 53

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
US	K251641	GF-310R Multigas Unit (GF-310R)	2026-08-12
US	K260747	YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff	2026-05-06
US	K251366	EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)	2025-10-09
BR	80914690017	Controle Hematológico MEK (5DN/5DH/5DL)	Class II
BR	80914690018	Controle Hematológico MEK (3DN/3DH/3DL)	Class II
BR	80914690016	Calibrador Hematológico MEK-CAL	Class II
SA	ME0000001174SFDAA00001	Defibrillation Pads	—
SA	ME0000015105SFDAA00003	Battery Pack	—
CA	8520	NEUROFAX EEG-2100, EEG-2110 AND EEG-2120 ELECTROENCEPHALOGRAPH	Class II
CA	8773	POCKETCAP OLG-1100A CO2 MONITOR	Class II
CA	13686	TELEMMETRY MONITORING SYSTEM WEP-8430A	Class II

Nihon Kohden Digital Health Solutions, LLC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies