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NIHON KOHDEN CORPORATION

Japan·JP-MF-000019022

Last updated May 27, 2026

What NIHON KOHDEN CORPORATION makes

Nihon Kohden Corporation manufactures medical extension cords, communication cables, and electrode leads for electrocardiogram (ECG) and electroencephalogram (EEG) systems, including limb and chest leads with varying cable lengths. The company also produces hematology control solutions for reticulocyte analysis and specialized rinsing solutions for laboratory equipment. These products are designed to interface with diagnostic and monitoring devices in clinical and research settings.

The company’s products are classified under various regulatory categories, including Class A, B, and C under the EU Medical Device Regulation (MDR), as well as Class I, II, IIa, and IIb under global standards. Devices are listed in the EU’s eudamed database and have undergone 510(k) clearance through the FDA’s premarket notification process. Nihon Kohden Corporation is headquartered in Japan.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: Japan
Address: 1-31-4, Nishiochiai，Shinjuku-ku　, Tokyo, Japan
Website: www.nihonkohden.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)325-0283
PRRC Contact: Yoshiyuki Fujita
EUDAMED SRN: JP-MF-000019022
FDA FEI Number: —
DUNS Number: 690568050

Catalogue (326)

Page 4 of 7

Device	Model / Reference	Registries	Class	Status
Bandpassfilter ZA-012P	ZA-012P	EUDAMED	Class I	Active
BR-201D limb lead F (2.5M) BR-201D	KA12F	EUDAMED	Class I	Active
Bandpassfilter ZA-011P	ZA-011P	EUDAMED	Class I	Active
BR-201D limb lead N (1.4M) BR-201D	KA13D	EUDAMED	Class I	Active
HEMATOLOGY CONTROL for reticulocyte MK-RE3	REM04	EUDAMED	Class B	Active
BR-201D limb lead L (2.0M) BR-201D	KA11E	EUDAMED	Class I	Active
ECG Connection Cord 10 JC-900PA	K921A	EUDAMED	Class I	Active
Bandpassfilter ZA-010P	ZA-010P	EUDAMED	Class I	Active
Eeg Electrode Set Be-403a	H467A	EUDAMED	Class I	Active
BR-201D chest lead C2 (0.7M) BR-201D	KA02A	EUDAMED	Class I	Active
HEMATOLOGY CONTROL for reticulocyte MK-RE2	RE204	EUDAMED	Class B	Active
SpO2 Connection Cord JL-400T	K939A	EUDAMED	Class I	Active
EEG Disk Electrode NE-116A	H503C	EUDAMED	Class I	Active
BR-201D chest lead C2 (1.2M) BR-201D	KA02C	EUDAMED	Class I	Active
Bandpassfilter ZA-013P	ZA-013P	EUDAMED	Class I	Active
Holder BD 0.5mL YZ-008B3	YZ-008B3	EUDAMED	Class A	Active
Extension Cord Ex212bk20	K297E	EUDAMED	Class I	Active
Electrode (with plastic holder) BE-0006	H542A	EUDAMED	Class I	Active
Lan Conversion Adapter Qi-940a	QI-940AK	EUDAMED	Class I	Active
YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff	K260747	FDA 510(k)	Class II	Active
Interface QF-909P	QF-909P	EUDAMEDFDA UDI	Class I	Active
Standard Accessory Kit A Yd-121d	YD-121D	EUDAMED	Class I	Active
Recorder Cable, 5M YS-108P1	YS-108P1	EUDAMEDFDA UDI	Class I	Active
Disposable Electrode VS-04IO4	G295A	EUDAMED	Class I	Active
Communication Cable IF-928P	IF-928P	EUDAMEDFDA UDI	Class I	Active
MEB-SEN connection cable JW-230B	JW-230B	EUDAMED	Class I	Active
Wireless LAN Connection Cable YS-104P9	YS-104P9	EUDAMED	Class I	Active
Heat Sensitive Paper FQW210-3-140	A054	EUDAMED	Class I	Active
Luer Cap Ys-094p0	P915	EUDAMED	Class I	Active
Ncs Electrode Nm-314ys	H694A	EUDAMED	Class I	Active
Disposable Electrode V-74018	G299Q	EUDAMED	Class I	Active
Eeg Acquisition Kit Di-962b	DI-962B	EUDAMED	Class I	Active
Electrode Lead 6 BR-946PA	K904D	EUDAMEDFDA UDI	Class I	Active
Watertrap Yg-300p	V924A	EUDAMED	Class I	Active
Connection Cable YS-112P7	YS-112P7	EUDAMED	Class I	Active
High heat Sensitive Paper FQW50-3-100	A723	EUDAMED	Class I	Active
Branch Cable, 5M YS-105P3	YS-105P3	EUDAMED	Class I	Active
High heat Sensitive Paper FQW50-2-100	A721	EUDAMED	Class I	Active
Battery Pack SB-950P	SB-950P-CL SB-950P-DB SB-950P-DB-30	EUDAMEDFDA UDI	Class I	Active
Pulse Oximeter OLV-4201	OLV-4201K	EUDAMED	Class IIb	Active
Elefix V Paste for EEG & EMG	K191975	FDA 510(k)	Class II	Active
EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)	K251366	EUDAMEDFDA 510(k)	Class II	Active
Nihon Kohden Wireless Input Unit WEE-1200	K171124	FDA 510(k)	Class II	Active
Nihon Kohden QP-160AK EEG Trend Program	K163644	FDA 510(k)	Class II	Active
Life Scope PT BSM-1700 Series Bedside Monitor	K220976	FDA 510(k)	Class II	Active
Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series	K201949	FDA 510(k)	Class II	Active
Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM	K213316	FDA 510(k)	Class II	Active
TG-970P CO2 Sensor Kit	K161860	FDA 510(k)	Class II	Active
Nihon Kohden Afib Detection Program QP-039P	K152305	FDA 510(k)	Class II	Active
Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System	K203435	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

NIHON KOHDEN EUROPE GmbH DE

Importers

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Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Nihon Kohden Corp. US