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Emdyca

Manufacturer

Nihon Kohden

Germany, India, Japan, United StatesLegal entities : NIHON KOHDEN CORPORATION, NIHON KOHDEN EUROPE GmbH, NIHON KOHDEN INDIA PRIVATE LIMITED

Markets : France · Germany · Italy · United States

Approvals : EU – class I, IIa, IIb, A, B, C · United States (FDA) – 510(k) : 199 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 34 · Italy 6 · Germany 2

EU representative : NIHON KOHDEN EUROPE GmbH (Germany)

Website information@db.nkc.co.jp

27 categories, 44 models including 44 on the market, 4 countries

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CategoryEMDN codeRegistered modelsClassContact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids) W0103010105
4 others
 A IVDR EUDAMED record Report an error
Gaseous exchange monitoring instruments - consumables Z1203020485 I MDR EUDAMED record Report an error
Defibrillators - hardware accessories Z12030580 I MDR EUDAMED record Report an error
Central information computing systems Z12030201 IIa, IIb MDR EUDAMED record Report an error
Limited panel cell counting analysers - hardware accessories W0202010280 A IVDR EUDAMED record Report an error
Multi-parameter monitors - consumables Z1203020285 I MDR EUDAMED record Report an error
Multilevel blood controls W0103010503 B IVDR EUDAMED record Report an error
Calibration plasma for haemostasis W0103020701 C IVDR EUDAMED record Report an error
Cardiac output measurement instruments - consumables Z12050585 I MDR EUDAMED record Report an error
Control plasma for haemostasis W0103020702 C IVDR EUDAMED record Report an error
D-dimer W0103020503 C IVDR EUDAMED record Report an error
Electrocardiographs - consumables Z12050385 I MDR EUDAMED record Report an error
Electroencephalographs Z12100302 IIa MDR EUDAMED record Report an error
Electroencephalography instruments - hardware accessories Z12100380 I MDR EUDAMED record Report an error
Multi-parameter monitors - hardware accessories Z1203020280 I MDR EUDAMED record Report an error
Multi-parameter patient bedside monitors Z1203020201 IIb MDR EUDAMED record Report an error
Peripheral or central neuro stimulation and assessment instruments - consumables Z12101185 I MDR EUDAMED record Report an error
Pulmonary ventilators for hospital use - consumables Z1203010585 I MDR EUDAMED record Report an error
Pulse oximeters Z1203020408 IIb MDR EUDAMED record Report an error
Semi-automatic defibrillators Z12030501 IIb MDR EUDAMED record Report an error
Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories Z1203019080 I MDR EUDAMED record Report an error
Various instruments to support and monitor vital signs - hardware accessories Z12039080 I MDR EUDAMED record Report an error
Video laryngoscopes Z12021004 I MDR EUDAMED record Report an error
Vital signs monitoring instruments - consumables Z12030285 I MDR EUDAMED record Report an error
Vital signs monitoring instruments - medical device software Z12030292 IIa MDR EUDAMED record Report an error
Vital signs telemetry instruments - hardware accessories Z1203020680 I MDR EUDAMED record Report an error
Vital signs telemetry receivers Z1203020602 IIb 93/42 EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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