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
Barco	K9300391A2X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K930792502	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301628B1X	EUDAMEDFDA UDI	Class IIa	Active
Nio 5.8MP Gray	K9300375C1X	EUDAMED	Class IIa	Active
Barco	K9352021B	EUDAMEDFDA UDI	Class I	Active
Barco	K9307949	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303163A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303151A	EUDAMEDFDA UDI	Class I	Active
Nio	K9300391A1X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303300I	EUDAMEDFDA UDI	Class I	Active
Barco	K9352362	EUDAMEDFDA UDI	Class I	Active
Nio	K9300330B1X	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300340B	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300361A	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303154A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303025A	EUDAMEDFDA UDI	Class I	Active
Barco	K9352403	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303153A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303300	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350200B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303301D	EUDAMEDFDA UDI	Class I	Active
Nio	K9300340A	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9352380	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301626B1X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9301638B2X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9352361	EUDAMEDFDA UDI	Class I	Active
Barco	K9352302	EUDAMEDFDA UDI	Class I	Active
Barco	K9307932	EUDAMEDFDA UDI	Class I	Active
Barco	991932204022	EUDAMEDFDA UDI	Class I	Active
Barco	K9307954B	EUDAMEDFDA UDI	Class I	Active
Barco	K9352051	EUDAMEDFDA UDI	Class I	Active
Barco	K9307948	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350202F	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303310B	EUDAMEDFDA UDI	Class I	Active
Barco	K9352151	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356035A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303330F	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350202I	EUDAMEDFDA UDI	Class I	Active
Barco	K9307938	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303331D	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356036A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303331CMS	EUDAMEDFDA UDI	Class I	Active
Barco	K9307919	EUDAMEDFDA UDI	Class I	Active
Barco	K9352401	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303321I	EUDAMEDFDA UDI	Class I	Active
Eonis	K9301820A	EUDAMEDFDA UDI	Class I	Active
Nio	K9300391A	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303300B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350201I	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356021A1X	EUDAMEDFDA UDI	Class I	Active

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