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
Nexxis OR	K9303078A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303274A	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356051A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303330B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320I	EUDAMEDFDA UDI	Class I	Active
Eonis	K9350281	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303331I	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307935	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356039A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303160A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320X	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356037A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350200I	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350204X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303098A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303028A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350204B	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307947	EUDAMED	Class I	Active
Nexxis OR	K9303300G	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303073A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303051A	EUDAMEDFDA UDI	Class I	Active
Eonis	K9301821ABR	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303330X	EUDAMEDFDA UDI	Class I	Active
QAWeb Enterprise	K5402921	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303164A	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356042A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303190A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303300F	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303330G	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301629B	EUDAMEDFDA UDI	Class IIa	Active
Barco	600301481	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307945B	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356041A1X	EUDAMEDFDA UDI	Class I	Active
Barco	K9307940	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307945BR	EUDAMEDFDA UDI	Class I	Active
Barco	K9307949B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307943B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350204F	EUDAMEDFDA UDI	Class I	Active
Barco	K9301101A2X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303320F	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301638A	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300372B1X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9352021	EUDAMEDFDA UDI	Class I	Active
Barco	991932391001	EUDAMEDFDA UDI	Class I	Active
Barco	K9307951B	EUDAMEDFDA UDI	Class I	Active
Barco	K9307950	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303311G	EUDAMEDFDA UDI	Class I	Active
Barco	K9352800	EUDAMEDFDA UDI	Class I	Active

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