Manufacturer

Fukuda

JapanLegal entities : Fukuda Denshi Co., Ltd.

Markets : Germany · Italy · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 70 · class I, II · latest in 2018 · see on the FDA website

EU representative : Emergo Europe B.V. (Netherlands)

info@fukuda.co.jp

10 categories, 17 models including 17 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Multi-parameter monitors - hardware accessories	Z1203020280	AC Unit3 refs Connection Cable CJ-523A3 refs Mounting Bracket for LW-1000	I, IIb MDR	EUDAMED record Report an error
Various instruments to support and monitor vital signs - hardware accessories	Z12039080	12-Lead Analysis Optional Software3 refs ECG Relay Cable CIT-13DIN series Patient Cable CMO-N series3 refs	I MDR	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	15-lead Patient Cable Hanger Attachment3 refs CardiMax FCP-81003 refs	I, IIa MDR	EUDAMED record Report an error
Vital signs monitoring instruments - software accessories	Z12030282	Data Management System EFS-10002 refs DynaBase	I MDR	EUDAMED record Report an error
Vital signs telemetry receivers	Z1203020602	Central Telemetry Receiver DS-1700L3 refs Central Telemetry Receiver LW-1000	IIb MDR	EUDAMED record Report an error
Electrocardiographs - hardware accessories	Z12050380	Multi-attachment for OTV-033 refs	I MDR	EUDAMED record Report an error
Electrocardiographs - software accessories	Z12050382	ECG Amplifier Unit2 refs	IIa MDR	EUDAMED record Report an error
Non-invasive blood pressure gauges - other	Z1203020599	Soft Cuff, APC CUF-85033 refs	I MDR	EUDAMED record Report an error
Vital signs telemetry instruments - hardware accessories	Z1203020680	Disposable Case （For LX-8100）3 refs	I MDR	EUDAMED record Report an error
Vital signs telemetry transmitter	Z1203020603	ECG & Respiration Transmitter model LX-8100 type LX-81003 refs	IIb MDR	EUDAMED record Report an error

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