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558 device results listed.

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Celltac chemi D-dimer DD-421W

D-DIMER

IVD Class CIVDR 2017/746On the marketAnimal tissuesMicrobial substancesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921050675
Basic UDI-DI: 4931921IVD0026P3
Reference: DD-421W
EMDN: W0103020503
EMDN description: D-DIMER
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

BEDSIDE MONITOR BSM-5732

General-purpose multi-parameter bedside monitor

Class IIbMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921039731
Basic UDI-DI: 4931921MD2b0004LY
Reference: BSM-5732K
EMDN: Z1203020201
EMDN description: MULTI–PARAMETER PATIENT BEDSIDE MONITORS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

HEMATOLOGY CONTROL+CRP MK-3CN

CONTROL BLOOD MULTILEVEL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921026090
Basic UDI-DI: 4931921IVD0010NL
Reference: 3CN03
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolynac･510 MK-510W

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921026045
Basic UDI-DI: 4931921IVD0018P4
Reference: T496D
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Hemolynac･310 MK-310W

CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

IVD Class AIVDR 2017/746On the marketProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921026038
Basic UDI-DI: 4931921IVD0017P2
Reference: T493D
EMDN: W0103010105
EMDN description: CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

EEG Amplifier Unit JE-940A

Electroencephalograph

Class IIaMDR 2017/745On the marketActive deviceMeasuring function

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921023143
Basic UDI-DI: 4931921MD2a0014LQ
Reference: JE-940AK
EMDN: Z12100302
EMDN description: ELECTROENCEPHALOGRAPHS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

HEMATOLOGY CONTROL for reticulocyte MK-RE1

CONTROL BLOOD MULTILEVEL

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921015438
Basic UDI-DI: 4931921IVD0012NQ
Reference: RE104
EMDN: W0103010503
EMDN description: MULTILEVEL BLOOD CONTROLS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Connection Cable 2.5m YJ-332Z

General- purpose intensive-care ventilator

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921012758
Basic UDI-DI: 4931921MD10005BF
Reference: YJ-332Z
EMDN: Z1203010585
EMDN description: PULMONARY VENTILATORS FOR HOSPITAL USE - CONSUMABLES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

MINI ELECTRODE JUNCTION BOX JE-944A

Electroencephalograph

Class IMDR 2017/745On the market

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921023044
Basic UDI-DI: 4931921MD10014BG
Reference: JE-944A
EMDN: Z12100380
EMDN description: ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Central Monitor CNS-2101

Centralized patient monitor

Class IIbMDR 2017/745On the marketActive deviceDirect marking

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921017166
Basic UDI-DI: 4931921MD2b0003LW
Reference: CNS-2101K
EMDN: Z12030201
EMDN description: CENTRAL INFORMATION COMPUTING SYSTEMS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi HbA1c N HA-421W

GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921008348
Basic UDI-DI: 4931921IVD0013NS
Reference: HA-421W
EMDN: W0102060109
EMDN description: GLYCOSYLATED/GLYCATED HAEMOGLOBIN (IC)
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Breakout Box　JB-910B

Evoked-potential graphic recording system

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921005477
Basic UDI-DI: 4931921MD10013BE
Reference: JB-910B
EMDN: Z12101180
EMDN description: PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Capillary adapter set(20μL) (for measuring CBC+CRP) YZ-008B6

AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - CONSUMABLES

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testingSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921005118
Basic UDI-DI: 4931921IVD0021NR
Reference: YZ-008B6
EMDN: W0202010280
EMDN description: LIMITED PANEL CELL COUNTING ANALYSERS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

SSD EXTENTION KIT YS-116P0

General-purpose multi-parameter bedside monitor

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921002223
Basic UDI-DI: 4931921MD10004BD
Reference: YS-116P0
EMDN: Z1203020280
EMDN description: MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi CRP 4N CR-421W

C-REACTIVE PROTEIN

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921001691
Basic UDI-DI: 4931921IVD0014NU
Reference: CR-421W
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

BR-201D chest lead C3 (2.0M) BR-201D

Electrocardiograph, professional, multichannel

Class IMDR 2017/745On the market

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921895986
Basic UDI-DI: 4931921MD10015BJ
Reference: KA03E
EMDN: Z12050385
EMDN description: ELECTROCARDIOGRAPHS - CONSUMABLES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

EXTENSION CORD EX212BK05

Evoked-potential graphic recording system

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921836415
Basic UDI-DI: 4931921MD10013BE
Reference: K295E
EMDN: Z12101185
EMDN description: PERIPHERAL OR CENTRAL NEURO STIMULATION AND ASSESSMENT INSTRUMENTS - CONSUMABLES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

Unit Connection Cable, 1M YS-107P1

General-purpose multi-parameter bedside monitor

Class IMDR 2017/745On the marketActive device

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921112489
Basic UDI-DI: 4931921MD10004BD
Reference: YS-107P1
EMDN: Z1203020285
EMDN description: MULTI-PARAMETER MONITORS - CONSUMABLES
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 09:39

Manufacturer products Authorised representative products Authorised representative actors View details

Central Station

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Nihon Kohden Digital Health Solutions LLC
Manufacturer SRN: US-MF-000042132
UDI-DI: 00851725007399
Basic UDI-DI: 0851725007CNSCS-001Y7
Reference: NA
EMDN: Z12030201
EMDN description: CENTRAL INFORMATION COMPUTING SYSTEMS
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details

00851725007375

NetKonnect Surveillance

Class IIaMDR 2017/745On the marketActive device

Manufacturer: Nihon Kohden Digital Health Solutions LLC
Manufacturer SRN: US-MF-000042132
UDI-DI: 00851725007375
Basic UDI-DI: 0851725007NKS-0014T
Reference: NA
EMDN: Z12030292
EMDN description: VITAL SIGNS MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 16.07.2026 06:35

Manufacturer products Authorised representative products Authorised representative actors View details