Manufacturer

Biocare

ChinaLegal entities : Shenzhen Biocare Bio-Medical Equipment Co., Ltd.

Markets : Bulgaria · Czechia · France · Hungary · Italy · Poland · Romania · Spain · Türkiye · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 12 · class I, II · latest in 2016 · see on the FDA website

Public contracts won : France 4

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

regulation@biocare.com.cn

9 categories, 21 models including 21 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
General purpose electrocardiographs	Z12050301	Digital Electrocardiograph ECG-121093/42 Digital Electrocardiograph ECG-200093/42 Digital Electrocardiograph iE 1093/42 Digital Electrocardiograph iE 10193/42 Digital Electrocardiograph iE 1293/42 5 others Digital Electrocardiograph iE 12A93/42 Digital Electrocardiograph iE 1593/42 Digital Electrocardiograph iE 393/42 Digital Electrocardiograph iE 30093/42 Digital Electrocardiograph iE 693/42	IIa 93/42	EUDAMED record Report an error
Multi-parameter patient bedside monitors	Z1203020201	Patient Monito iM 1293/42 Patient Monitor iM 1593/42 Patient Monitor PM-90093/42	IIb 93/42	EUDAMED record Report an error
Foetal monitors	Z12080101	Fetal Monitor FM-80193/42 Fetal Monitor SmartFM93/42	IIb 93/42	EUDAMED record Report an error
Blood pressure holter recorders	Z12050404	Ambulatory Blood Pressure Recorders and Associated Software iH-B	IIa MDR	EUDAMED record Report an error
Central information computing systems	Z12030201	Central Monitoring System PM-200093/42	IIb 93/42	EUDAMED record Report an error
ECG holter recorders	Z12050403	Ambulatory Electrocardiographs iH-12PLUS，iH-3PLUS2 refs	IIa MDR	EUDAMED record Report an error
Foetal heartbeat detectors	Z12080103	Doppler Fetal Heart Rate Detector FM-20093/42	IIa 93/42	EUDAMED record Report an error
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)	Z11040104	B-Ultrasonic Diagnostic Equipment BU-90793/42	IIa 93/42	EUDAMED record Report an error
Pulse oximeters	Z1203020408	Fingertip Pulse Oximeter BP-10M93/42	IIb 93/42	EUDAMED record Report an error

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