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Bayer Medical Care Inc.

United States·US-MF-000007050

Last updated September 17, 2026

What Bayer Medical Care Inc. makes

The company manufactures disposable and reusable components for contrast medium injection, including angiographic syringes, radiographic tubing, and mobile injection systems for CT and angiography procedures. It also produces MRI-specific radio-frequency coils and battery-powered contrast injection systems, alongside hand controller kits and general-purpose fluid transfer sets. Devices like the MEDRAD® Vflow Hand Controller and Stellant CT Injection System are designed for precise contrast delivery in diagnostic imaging.

The portfolio includes devices classified as Class I, Class II, Class IIa, and Class IIb under global regulatory frameworks. Products are listed in the EU’s eudamed registry and the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Bayer Medical Care Inc. manufacture?

Bayer Medical Care Inc. specializes in disposable and reusable medical devices primarily used in diagnostic imaging. Their portfolio includes angiographic syringes, radiographic procedure tubing, mobile contrast medium injection systems for CT and angiography, MRI-specific radio-frequency coils, battery-powered contrast injection systems, hand controller kits, and general-purpose fluid transfer sets. These devices are designed to support precise contrast medium delivery and fluid management in procedures like CT scans, angiography, and MRI.

Where is Bayer Medical Care Inc. based, and how does that affect its regulatory standing?

Bayer Medical Care Inc. is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including the requirement for listing in the FDA’s Unique Device Identifier (UDI) database. Additionally, some of its devices are listed in the EU’s eudamed registry, indicating their availability or registration in the European market under applicable EU medical device regulations.

Which regulatory registries list Bayer Medical Care Inc.’s devices, and why is this important?

Bayer Medical Care Inc.’s devices are listed in two key regulatory registries: the EU’s eudamed and the FDA’s Unique Device Identifier (UDI) database. Listing in eudamed ensures visibility and traceability of devices marketed in the European Economic Area, while inclusion in the FDA’s UDI database facilitates regulatory oversight, post-market surveillance, and transparency in the U.S. market. These registries help healthcare providers, regulators, and patients access critical information about the devices’ identification, classification, and compliance status.

How are Bayer Medical Care Inc.’s devices classified under global regulatory frameworks?

Bayer Medical Care Inc.’s devices are classified under various risk-based categories, including Class I, Class II, Class IIa, and Class IIb. Classification determines the regulatory controls applied to ensure safety and performance. For example, Class IIb devices typically involve higher risks and require more stringent pre-market evaluations, such as clinical data or special controls, compared to Class I devices, which generally pose minimal risk. The classification ensures that devices are assessed proportionally to their potential impact on patient safety.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 1, Bayer Drive, Indianola, United States
Website: bayer.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Joseph Kridgen
EUDAMED SRN: US-MF-000007050
FDA FEI Number: 2520313
DUNS Number: —

Catalogue (477)

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Device	Model / Reference	Registries	Class	Status
MEDRAD® Mark 7 Arterion Handswitch 12’ Optional	ART 700 HS12	EUDAMEDFDA UDI	Class II	Active
Maintain, Syringe Heat, Envision, Udi, Batch	ESH 700	FDA UDI	Class II	Active
MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve	SSIT 96VLD	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX Syringe Kit	FLEXD-200-QFT	FDA UDI	Class II	Active
MEDRAD® Veris™ 8600 Vital Signs Monitor	3012634	FDA UDI	Class II	Active
Disposable MRI Kit with Check Valve	SQK 65VS	FDA UDI	Class II	Active
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector	SIT 96V	FDA UDI	Class II	Active
Cbl, Handswitch, 20', Head, Mct2.0, Udi, Batch	EHS 700 20	FDA UDI	Class II	Active
Female - Female Adapter	FFA 50	FDA UDI	Class II	Active
MEDRAD® Mark V ProVis 150mL FasTurn Sterile Disposable Syringe	150-FT	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX Syringe Kit	FLEXS-150-QFT	FDA UDI	Class II	Active
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube	SSS-LP-60-T	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX Syringe Kit	FLEXS-200-QFT	FDA UDI	Class II	Active
Swabbable Valve Transfer Set	SVTS	FDA UDI	Class II	Active
Cable, Handswitch, 5', Dcu, Udi, Batch	EDS 700 05	FDA UDI	Class II	Active
MEDRAD® Avanta Fluid Management Injection System	Avanta	FDA UDI	Class II	Active
CT TRI-PAK Sterile Disposable Syringe	CTP-200-FLS	FDA UDI	Class II	Active
MEDRAD® Spectris Solaris EP MR Injection System	CHD 400 MR	FDA UDI	Class II	Active
MEDRAD® TMJ Positioning Device and Mouthpeices	TMJ 250	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SSS-CTP-SPK	FDA UDI	Class II	Active
MEDRAD® Mark V ProVis 60mL FasTurn Sterile Disposable Syringe & QFT	60-FT-Q	FDA UDI	Class II	Active
MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube	TAG 150 SYR	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-QFT	FDA UDI	Class II	Active
Female Luer Transfer Set	FTS	FDA UDI	Class II	Active
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube	SSS-LP-60-T	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-SCS	FDA UDI	Class II	Active
Low Pressure Connector Tubing Integral “T” with Check Valve	LP-96-T-CV	EUDAMEDFDA UDI	Class II	Active
MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube	ART 700 SYR	FDA UDI	Class II	Active
MEDRAD® eCoil Imaging System (for Philips Ingenia)	4598 001 13811	FDA UDI	Class II	Active
MEDRAD® XDS Patient Interface Disposable	XDS PID	FDA UDI	Class I	Active
Assy, Cbl, Strt Sw, Aux, 60ft, Prov, Udi, Batch	KMA 550IR 60	FDA UDI	Class II	Active
MEDRAD® Vflow Disposable Hand Controller	VF HC	FDA UDI	Class II	Active
MEDRAD® 1.5T eCoil Interface Device (for Siemens)	FID SYM	FDA UDI	Class II	Active
MEDRAD® PRO-TEKT Endorectal Balloon	PROT 50	FDA UDI	Class I	Active
MEDRAD® Stellant Imaging System Interface ISI 700 Module	ISI 700	FDA UDI	Class II	Active
Saline Syringe & Tubing for MR Injector System	SSQK 115	FDA UDI	Class II	Active
48” (122 cm) High Pressure Connector Tube	DCT 148	FDA UDI	Class II	Active
MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube	TAG 150 SYR	FDA UDI	Class II	Active
Cable, Foot Switch Assy, Udi, Batch	KMA 562-1	FDA UDI	Class II	Active
Disposable MRI Kit with Check Valve	SQK 65VA	FDA UDI	Class II	Active
MEDRAD® Avanta Multi-Patient Disposable Set	AVA 500 MPAT (Part 2 or 2)	FDA UDI	Class II	Active
Disposable MRI Kit for 65/115 MR Injector System	SSQK 65/115VS	FDA UDI	Class II	Active
MEDRAD® eCoil Imaging System (for Philips Ingenia)	9896 030 19031	FDA UDI	Class II	Active
MEDRAD® Stellant CT Injection System	Stellant SX	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe &Spike	SSS-SPK	FDA UDI	Class II	Active
MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 120cm (48in)	TAG C120 HPCT	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe 200mL Syringe & Spike	SSS-SPK	FDA UDI	Class II	Active
MEDRAD® Manual Syringe Loader	SMR LDR	FDA UDI	Class II	Active
MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube	ART 700 SYR	FDA UDI	Class II	Active
Saline Syringe & Tubing for MR Injector System	SSQK 115	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Bayer Medical Care B.V. NL

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Bayer Medical Care Inc. has nine FDA recall records initiated between June 28, 2018, and April 24, 2026. The records include open, classified, and terminated statuses, with reasons involving potential product defects such as black specks in needles, leaks in syringe kits, loose particulate from dust caps, labeling errors, mechanical disengagement risks in injector systems, and issues related to torque specifications on ceiling column assemblies. Supplier changes and fit problems with contrast flow control valves were also cited as contributing factors in some cases.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Apr 24, 2026	Z-2296-2026	—	open, classified	Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
Nov 30, 2022	Z-0910-2023	—	open, classified	Black specks may be present on the packaged needles
Sep 14, 2021	Z-0199-2022	—	terminated	Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Oct 5, 2020	Z-0483-2021	—	terminated	Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Dec 14, 2018	Z-0745-2019	—	terminated	If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
Sep 7, 2018	Z-0097-2019	—	terminated	Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
Jun 28, 2018	Z-2960-2018	—	terminated	The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Jun 28, 2018	Z-2961-2018	—	terminated	The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Jun 28, 2018	Z-2962-2018	—	terminated	The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.