Manufacturer

Sino-Hero(Shenzhen) Bio-Medical Electronics

ChinaLegal entities : Sino-Hero(Shenzhen) Bio-Medical Electronics Co., LTD.

Markets : Bulgaria · Cyprus · Czechia · France · Poland · Romania · Türkiye

Approvals : EU – class I, IIa, IIb

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

6 categories, 27 models including 27 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Transportable/portable multi-parameter patient monitors	Z1203020202	Handheld monitor SM5093/42 Handheld monitor SM8093/42 Patient monitor AcuitsignM393/42 Patient monitor AcuitsignM593/42 Patient monitor AcuitsignM693/42 12 others Patient monitor H593/42 Patient monitor H893/42 Patient monitor iS1093/42 Patient monitor iS10Express93/42 Patient monitor iS1593/42 Patient monitor mTouch693/42 Patient monitor mTouch893/42 Patient monitor S1293/42 Patient monitor S60Vista93/42 Patient monitor S8093/42 Patient monitor S9093/42 Patient monitor S90Express93/42	IIb 93/42	EUDAMED record Report an error
General purpose electrocardiographs	Z12050301	Electrocardiogragh SE120093/42 Electrocardiogragh SE1200Lite93/42 Electrocardiogragh SE50893/42 Electrocardiogragh SE50993/42	IIa 93/42	EUDAMED record Report an error
Pulse oximeters	Z1203020408	Pulse Oximeter S693/42 Pulse Oximeter S893/42 Pulse Oximeter S993/42	IIa, IIb 93/42	EUDAMED record Report an error
Multi-parameter monitors - consumables	Z1203020285	Pulse Oximeter Probes SH0101&81 series93/42	IIb 93/42	EUDAMED record Report an error
Non-invasive blood pressure monitoring instruments	Z1203020302	NIBP cuff SH0118	I MDR	EUDAMED record Report an error
Portable ultrasound scanners	Z11040103	CU-1093/42	IIa 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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