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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
LinkedIn
—
Facebook
—
Phone
+1(800)325-0283
PRRC Contact
Yoshiyuki Fujita
EUDAMED SRN
JP-MF-000019022
FDA FEI Number
—
DUNS Number
690568050

Catalogue (322)

Page 2 of 7
DeviceModel / ReferenceRegistriesClassStatus
Hematology Control+crp Mk-3cl 3CLH3
EUDAMED
Class BActive
BR-203D chest lead X-(1.0M) BR-203D KC15B
EUDAMED
Class IActive
Heat Sensitive Paper Fqw210-10-295 A052
EUDAMED
Class IActive
Extension Cord Ex212wh10 K296D
EUDAMED
Class IActive
Hematology Control+crp Mk-3cn 3CN12
EUDAMED
Class BActive
BR-203DA limb lead LA(1.2M) BR-203DA KC31C
EUDAMED
Class IActive
BR-203D limb lead F(1.4M) BR-203D KC12D
EUDAMED
Class IActive
Extension Cord Ex212re20 K297A
EUDAMED
Class IActive
CHM cleaning kit YZ-006B0 T438W
EUDAMED
Class AActive
BR-203D chest lead CX2(0.7M) BR-203D KC08A
EUDAMED
Class IActive
BR-201D chest lead C4 (0.7M) BR-201D KA04A
EUDAMED
Class IActive
BR-201D chest lead C2 (2.0M) BR-201D KA02E
EUDAMED
Class IActive
BR-203D limb lead F(0.7M) BR-203D KC12A
EUDAMED
Class IActive
BR-203D XYZ-lead set BR-203D KC012
EUDAMED
Class IActive
BR-203D limb lead N(0.7M) BR-203D KC13A
EUDAMED
Class IActive
Extension Cord Ex212pr10 K296G
EUDAMED
Class IActive
BR-203D chest lead CX1(0.7M) BR-203D KC07A
EUDAMED
Class IActive
BR-203D chest lead C5(0.7M) BR-203D KC05A
EUDAMED
Class IActive
Extension Cord Bm-211s K612
EUDAMED
Class IActive
KABEVETTE G Kit YZ-008B2 YZ-008B2
EUDAMED
Class AActive
BR-201D chest lead C3 (2.0M) BR-201D KA03E
EUDAMED
Class IActive
BR-203D limb lead L(0.7M) BR-203D KC11A
EUDAMED
Class IActive
Extension Cord Ex212ye05 K295A
EUDAMED
Class IActive
Hemolynac・510 MK-510W T496D
EUDAMED
Class AActive
Bandpassfilter ZA-015P ZA-015P
EUDAMED
Class IActive
Isotonac・3 Mek-640 T436D
EUDAMED
Class AActive
Extension Cord Ex212bw05 K295F
EUDAMED
Class IActive
BR-201D chest lead C6 (1.2M) BR-201D KA06C
EUDAMED
Class IActive
BR-201D chest lead CX2 (1.4M) BR-201D KA08D
EUDAMED
Class IActive
Celltac chemi HbA1c N HA-421W HA-421W
EUDAMED
Class CActive
BR-201D limb lead R (1.2M) BR-201D KA10C
EUDAMED
Class IActive
BR-201D chest lead C5 (0.7M) BR-201D KA05A
EUDAMED
Class IActive
BR-203DA 12-lead set BR-203DA KC013
EUDAMED
Class IActive
Cleanac・710 Mk-710w T438H
EUDAMED
Class AActive
Shield Junction Cord BM-090Y K640A
EUDAMED
Class IActive
BR-201D chest lead C6 (2.0M) BR-201D KA06E
EUDAMED
Class IActive
DC Power Cord for NANAO Display, 2.8M YS-108P3 YS-108P3
EUDAMED
Class IActive
Thermal Airflow Sensor TR-190A P916A
EUDAMED
Class IActive
Extension Cord Bm-003b K625C
EUDAMED
Class IActive
BR-201D chest lead CX2 (0.7M) BR-201D KA08A
EUDAMED
Class IActive
Extension Cord Ex212ye20 K297B
EUDAMED
Class IActive
Celltac chemi CRP 4N CR-421W CR-421W
EUDAMED
Class BActive
Hemolynac・310 MK-310W T493D
EUDAMED
Class AActive
BR-203DA Exercise test leads set BR-203DA KC014
EUDAMED
Class IActive
Hemolynac・3N MEK-680 T497
EUDAMED
Class AActive
BR-201D chest lead C3 (1.2M) BR-201D KA03C
EUDAMED
Class IActive
BR-203D chest lead C1(0.7M) BR-203D KC01A
EUDAMED
Class IActive
"D-dimer Control DD-QC" DD-QC
EUDAMED
Class CActive
Isotonac・3 Mek-640 T436J
EUDAMED
Class AActive
BR-203DA limb lead RL(0.7M) BR-203DA KC33A
EUDAMED
Class IActive

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FDA Establishments (1)

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

  • Nihon Kohden Corp. US