Manufacturer

Shanghai United Imaging Healthcare

ChinaLegal entities : Shanghai United Imaging Healthcare Co.,Ltd.

Markets : Ireland · Italy · Poland · Romania · United States

Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 86 · class II · latest in 2026 · see on the FDA website

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

services@united-imaging.com

24 categories, 72 models including 72 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
CT/PET systems	Z11020301	uEXPLORER93/42 uMI 55093/42 uMI 78093/42 uMI Panorama 28 uMI Panorama 35 8 others uMI Panorama GS uMI Panvivo uMI Panvivo ES uMI Panvivo EX uMI Panvivo LS uMI Panvivo M uMI Panvivo S uMI Vista	IIb MDR, 93/42	EUDAMED record Report an error
Direct digital teleradiographs	Z11031102	uDR 266i93/42 uDR 380i93/42 uDR 380i Pro93/42 uDR 566i-A uDR 566i-B 5 others uDR 596i93/42 uDR 760i93/42 uDR 780i Pro93/42 uDR Arria uDR Aurora CX	IIb MDR, 93/42	EUDAMED record Report an error
Digital mammography systems	Z11030202	uMammo 590h uMammo 590i93/42 uMammo 590u uMammo 870i uMammo 890i93/42	IIb MDR, 93/42	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field greater than 2t and less than or equal to 4t	Z11050105	uMR 7802 refs uMR Astra uMR Omega uMR Ultra	IIa MDR, 93/42	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field less than or equal to 2t	Z11050104	uMR 580 uMR 588 uMR 670 uMR 680	IIa MDR	EUDAMED record Report an error
Computed tomographs - 16 layers or more but less than 64 layers	Z11030603	uCT 52093/42 uCT 52893/42 uCT Orion Elite uCT Orion Extra	IIb MDR, 93/42	EUDAMED record Report an error
Computed tomographs - 256 layers or more	Z11030607	Computed Tomography X-ray System uCT SiriuX uCT 868 uCT 960+ uCT SiriuX Ultrix	IIb MDR	EUDAMED record Report an error
Computed tomographs - 128 layers or more but less than 256 layers	Z11030606	uCT 76093/42 uCT 780 uCT 820	IIb MDR, 93/42	EUDAMED record Report an error
Digital angiography systems - medical device software	Z11030192	uWS-Angio Pro Software uWS-Angio Software uWS-Angio Software uWS-Angio Basic	IIa MDR	EUDAMED record Report an error
Computed tomographs (CT) - medical device software	Z11030692	uOmnispace.CT uWS-CT	IIa MDR	EUDAMED record Report an error
Fluoroscopy devices	Z11039009	uMC Reveal E uMC Reveal X	IIb MDR	EUDAMED record Report an error
Integrated CT/PET systems - medical device software	Z11020392	uOmnispace.MI uWS-MI	IIa MDR, 93/42	EUDAMED record Report an error
Linear accelerators - medical device software	Z11010192	uIPW uTPS OmniplanTx	IIb MDR	EUDAMED record Report an error
Magnetic resonance (mr) systems - medical device software	Z11050192	uOmnispace.MR2 refs uWS-MR	IIa MDR	EUDAMED record Report an error
MRI/PET systems	Z11020701	Positron Emission Tomography and Magnetic Resonance Imaging System uPMR Zenith uPMR 79093/42	IIa MDR, 93/42	EUDAMED record Report an error
Single energy linear accelerators	Z11010101	uLinac EternaTx uRT-linac 506c	IIb MDR	EUDAMED record Report an error
Closed magnet MRI scanners with magnetic field greater than 4t	Z11050106	uMR Jupiter	IIa MDR	EUDAMED record Report an error
Computed tomographs - 64 layers or more but less than 128 layers	Z11030605	uCT 550	IIb MDR	EUDAMED record Report an error
Mammography systems - medical device software	Z11030292	uWS-DBT93/42	IIa 93/42	EUDAMED record Report an error
Mobile radioscopic units	Z11039017	uMC 560i	IIb MDR	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	uOmnispace	IIa MDR	EUDAMED record Report an error
Remote control tables - medical device software	Z11030792	uOmniscan	IIa MDR	EUDAMED record Report an error
Stationary angiography systems for angiographic and cardiologic studies	Z11030102	uAngio AVIVA CX	IIb MDR	EUDAMED record Report an error
Stereotactic modules for mammography	Z1103028001	uStereo	IIb MDR	EUDAMED record Report an error

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