Manufacturer

Bayer

United StatesLegal entities : Bayer Medical Care Inc.

Markets : Belgium · Czechia · France · Italy · Netherlands · United States

Approvals : EU – class I, IIb · United States (FDA) – 510(k) : 197 · PMA : 4 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 34 · Italy 18 · Czechia 3 · Belgium 1

EU representative : Bayer Medical Care B.V. (Netherlands)

6 categories, 10 models including 8 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Angiographic injectors	Z11039013	MEDRAD® Avanta Fluid Management Injection System3 refs MEDRAD® Mark 7 Arterion Injection System2 refs MEDRAD® Stellant CT Injection System with Certegra Workstation	IIb MDR	EUDAMED record Report an error
Magnetic resonance injectors	Z11059001	MEDRAD® MRXperion MR Injection System MEDRAD® Spectris Solaris EP MR Injection System (no longer marketed)	IIb MDR	EUDAMED record Report an error
Various magnetic resonance imaging instruments - hardware accessories	Z11059080	MEDRAD® MRXperion MR Injection System3 refs MEDRAD® Spectris Solaris EP MR Injection System Accessories (no longer marketed)	I MDR	EUDAMED record Report an error
Infusion pumps	Z12030301	MEDRAD® Intego PET Infusion System	IIb MDR	EUDAMED record Report an error
Radiology instruments - medical device software	Z11030592	Radimetrics® Enterprise Application	I MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - other	Z119099	MEDRAD® ISI2 Module	I 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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