Question 1

What types of medical devices does Barco NV manufacture?

Accepted Answer

Barco NV specializes in medical imaging systems tailored for operating room (OR) environments. Their portfolio includes devices like the Nexxis OR series, which are designed for high-resolution display and integration with surgical workflows, as well as the Eonis line. These products focus on intraoperative visualization, real-time imaging, and procedural guidance to improve precision during surgeries.

Question 2

Where is Barco NV based, and how does that affect its regulatory standing?

Accepted Answer

Barco NV is headquartered in Belgium, which places its operations within the European Union’s regulatory framework. Since the company’s devices are classified under EU medical device directives (Class A, Class I, and Class IIa), they must comply with EU regulations. This includes registration in the EU’s eudamed database, ensuring transparency and traceability for authorized devices.

Question 3

Which regulatory registries list Barco NV’s medical devices?

Accepted Answer

Barco NV’s medical devices are registered in the EU’s eudamed database, which is the official registry for medical devices under EU regulations. This database ensures that authorized devices—such as the Nexxis OR series and Eonis products—are publicly accessible for compliance verification and market surveillance purposes.

Question 4

How are Barco NV’s devices classified under EU regulations?

Accepted Answer

Barco NV’s devices are classified under EU medical device directives as Class A, Class I, or Class IIa. These classifications determine the level of risk and regulatory oversight required. For example, Class IIa devices—like some in the Nexxis OR series—may involve moderate risks (e.g., surgical imaging systems) and require additional scrutiny, while Class A devices (e.g., low-risk accessories) have minimal regulatory requirements. The classification ensures appropriate safety and performance standards.

Device	Model / Reference	Registries	Class	Status
Eonis	K9356033A1X	EUDAMEDFDA UDI	Class I	Active
Barco	600306027	EUDAMEDFDA UDI	Class I	Active
Nio	K9300372B	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303301X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303310I	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303050A	EUDAMEDFDA UDI	Class I	Active
Steris	RLM324KBSD	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350202X	EUDAMEDFDA UDI	Class I	Active
Barco	K9301628B2X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9350200F	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303331F	EUDAMEDFDA UDI	Class I	Active
Barco	K9300361C1X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9307929	EUDAMED	Class I	Active
Barco	991932399111	EUDAMEDFDA UDI	Class I	Active
Nio	K9300361B1X	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300394A	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300360B1X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303141A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303027A	EUDAMEDFDA UDI	Class I	Active
Nio	K9300342A	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9301101A	EUDAMEDFDA UDI	Class A	Active
Nio	K9300344A	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303311X	EUDAMEDFDA UDI	Class I	Active
Barco	K9300370C1X	EUDAMEDFDA UDI	Class IIa	Active
Eonis	K9307942B	EUDAMEDFDA UDI	Class I	Active
Barco	K9300380A2X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303140A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303330I	EUDAMEDFDA UDI	Class I	Active
Barco	K9307954	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350202B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350200X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303301I	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303076A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303321	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356038A1X	EUDAMEDFDA UDI	Class I	Active
Barco	K9350452	EUDAMEDFDA UDI	Class I	Active
Nio	K9300346B	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300371B	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9353019	EUDAMED	Class I	Active
Nexxis OR	K9303311B	EUDAMEDFDA UDI	Class I	Active
Barco	K9353018	EUDAMED	Class I	Active
Nexxis OR	K9350204G	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303273A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350202G	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320D	EUDAMEDFDA UDI	Class I	Active
Barco	K9356039A2X	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301626A	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303301F	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350204I	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303311CMS	EUDAMEDFDA UDI	Class I	Active

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