Manufacturer

Neusoftmedical

ChinaLegal entities : Neusoft Medical Systems Co., Ltd.

Markets : Bulgaria · Greece · Hungary · Ireland · Netherlands · Poland · Romania · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 23 · class II · latest in 2023 · see on the FDA website

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

11 categories, 25 models including 25 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
High voltage X-ray generators	Z11039011	G100NL-50F93/42 G100NL-65F93/42 G100NL-80F93/42 Lunar-50-RF93/42 Lunar-65-RF93/42 3 others Lunar-80-RF93/42 Venus-32-R93/42 Venus-50-R93/42	IIb 93/42	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - medical device software	Z119092	AVW 293/42 AVW.CT 193/42 AVW.MR 193/42 AVW.XRay 193/42	IIa 93/42	EUDAMED record Report an error
Computed tomographs - 16 layers or more but less than 64 layers	Z11030603	NeuViz 128 NeuViz 16 Classic93/42 NeuViz 16 Essence93/42	IIb MDR, 93/42	EUDAMED record Report an error
Mobile radiographic units	Z11039016	NeuVision 550M Plus93/42 NeuVision 560M	IIb MDR, 93/42	EUDAMED record Report an error
Multifunctional systems for direct digital radiology	Z11031101	NeuVision 46093/42 NeuVision 850	IIb MDR, 93/42	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t	Z11050104	NeuMR 1.5T	IIa MDR	EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers	Z11030606	NeuViz Prime93/42	IIb 93/42	EUDAMED record Report an error
Computed tomographs - 64 layers or more but less than 128 layers	Z11030605	NeuViz 64 In93/42	IIb 93/42	EUDAMED record Report an error
Digital mammography systems	Z11030202	NeuCare Mammo DR HD93/42	IIb 93/42	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	Global 193/42	IIa 93/42	EUDAMED record Report an error
Stationary angiography systems for angiographic and cardiologic studies	Z11030102	NeuAngio 30C	IIb MDR	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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