Manufacturer

Shimadzu

JapanLegal entities : Shimadzu Corporation

Markets : Belgium · Croatia · France · Germany · Italy · Netherlands · Slovenia · United States

Approvals : EU – class IIa, IIb, A · United States (FDA) – 510(k) : 149 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Croatia 52 · France 15 · Slovenia 3 · Belgium 1 · Italy 1

EU representative : Shimadzu Europa GmbH (Germany)

Website

14 categories, 81 models including 81 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
X-ray tube assembly	Z11039012	0.6/1.2P326D-15093/42 X-ray tube assembly 0.2/0.8P38C-8593/42 X-ray tube assembly 0.2/0.8P39CK-8593/42 X-ray tube assembly 0.3/0.8P18DK-8593/42 X-ray tube assembly 0.3/0.8P323DK-8593/42 28 others X-ray tube assembly 0.3/0.8P324DK-8593/42 X-ray tube assembly 0.4/0.7JG326D-2652 refs93/42 X-ray tube assembly 0.4/0.7JG326D-265 X-ray tube assembly J-series3 refs X-ray tube assembly 0.6/1.2P123DK-8593/42 X-ray tube assembly 0.6/1.2P13DK-8593/42 X-ray tube assembly 0.6/1.2P164DK-8593/42 X-ray tube assembly 0.6/1.2P18DE-8593/42 X-ray tube assembly 0.6/1.2P323DK-8593/42 X-ray tube assembly 0.6/1.2P324DK-1252 refs93/42 X-ray tube assembly 0.6/1.2P324DK-852 refs93/42 X-ray tube assembly 0.6/1.2P326D-15093/42 X-ray tube assembly 0.6/1.2P33DK-852 refs93/42 X-ray tube assembly 0.6/1.2P364DK-1252 refs93/42 X-ray tube assembly 0.6/1.2P364DK-852 refs93/42 X-ray tube assembly 0.6/1.2P366D-1502 refs93/42 X-ray tube assembly 0.6/1.2P38DE-852 refs93/42 X-ray tube assembly 0.6/1J327C-28093/42 X-ray tube assembly 0.7/1.2JG326D-2652 refs93/42 X-ray tube assembly 0.7/1.3U163C-363 refs93/42 X-ray tube assembly 0.7U161CS-3693/42 X-ray tube assembly 0.7U163CS-3693/42 X-ray tube assembly 0.8P323DK-8593/42 X-ray tube assembly 0.8P324DK-8593/42 X-ray tube assembly 1.2U161CS-314 refs93/42 X-ray tube assembly 1/2P13DK-8593/42 X-ray tube assembly 1/2P18DK-8593/42 X-ray tube assembly 1/2P33D-8593/42 X-ray tube assembly 1/2P38D-8593/42	IIb MDR, 93/42	EUDAMED record Report an error
Teleradiographs	Z11030506	EZy-Rad Pro6 refs93/42 FDR Go93/42 FDR Visionary Suite8 refs93/42 GENERAL RADIOGRAPHIC SYSTEM EZy-Rad Pro4 refs93/42 Mobile X-ray System Mobirex i92 refs93/42 6 others Mobile X-ray System MUX-106 refs93/42 MobileArt Evolution8 refs93/42 MobileDaRt Evolution2 refs93/42 Radiography System RADspeed fit5 refs93/42 RADspeed fit5 refs93/42 RADspeed Pro21 refs93/42	IIb 93/42	EUDAMED record Report an error
Mass - spectrometry system	W020303	APCI-805098/79 CLAM-2030 CL98/79 CLAM-2040 CL Fully Automated Sample Preparation Module for LCMS LabSolutions LCMS CL version 1.198/79 LCMS-8045 CL Liquid Chromatograph Mass Spectrometer3 refs 2 others LCMS-8050 CL98/79 LCMS-8060 CL98/79	A IVDR, 98/79	EUDAMED record Report an error
Column stands for radiological equipment	Z11030501	X-RAY RADIOGRAPHY STAND BR-1204 refs X-RAY RADIOGRAPHY STAND BR-120M3 refs93/42 X-ray Radiography Stand BR-120T3 refs93/42 X-RAY TUBE STAND FH-20HR93/42 X-RAY TUBE STAND FH-21HR93/42	IIb MDR, 93/42	EUDAMED record Report an error
Radiology instruments - other	Z11030599	FDR Visionary Suite3 refs Mobile X-ray System FDR Go2 refs Mobile X-ray System MobileDaRt Evolution3 refs Mobile X-ray System Mobirex i92 refs RADspeed Pro3 refs	IIb MDR	EUDAMED record Report an error
High performance liquid chromatography systems	W0201050201	LabSolutions LC CL Add PDA98/79 LabSolutions LC CL Multi LC98/79 Nexera CL HPLC SYSTEM HIGH PERFORMANCE LIQUID CHROMATOGRAPH	A IVDR, 98/79	EUDAMED record Report an error
High voltage X-ray generators	Z11039011	X-RAY HIGH VOLTAGE GENERATOR UD150B-4093/42 X-RAY HIGH VOLTAGE GENERATOR UD150L-4093/42 X-RAY HIGH VOLTAGE GENERATOR UD150L-40E2 refs93/42	IIb 93/42	EUDAMED record Report an error
Patient tables for radiological equipment	Z11030503	X-ray radiography table BK-120MK X-ray radiography table BK-12HK X-ray Radiography Table BK-2003 refs	IIb MDR, 93/42	EUDAMED record Report an error
Ceiling stands for radiological equipment	Z11030502	CEILING TYPE X-RAY TUBE SUPPORT CH-2004 refs Ceiling Type X-ray Tube Support CH-200M2 refs93/42	IIb MDR, 93/42	EUDAMED record Report an error
Digital remote control tables	Z11030702	FLUOROspeed93/42 X-RAY TV SYSTEM SONIALVISION G43 refs	IIb MDR, 93/42	EUDAMED record Report an error
Radiology instruments - hardware accessories	Z11030580	Collimator Type R-20J2 refs93/42 COLLIMATOR TYPE R-3005 refs93/42	IIb 93/42	EUDAMED record Report an error
Remote control tables - hardware accessories	Z11030780	OPESCOPE ACTENO12 refs93/42 SURGICAL MOBILE C-ARM IMAGING SYSTEM OPESCOPE ACTENO5 refs	IIb MDR, 93/42	EUDAMED record Report an error
Stationary angiography systems for angiographic and cardiologic studies	Z11030102	Digital Angiography System Trinias30 refs93/42 Trinias23 refs93/42	IIb 93/42	EUDAMED record Report an error
Radiology instruments - software accessories	Z11030582	UT-Station93/42	IIa 93/42	EUDAMED record Report an error

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