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	K9356031A1X	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301629A	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9352240	EUDAMEDFDA UDI	Class I	Active
Nio	K9300370B1X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9356040A2X	EUDAMEDFDA UDI	Class I	Active
Barco	K9307928	EUDAMED	Class I	Active
Coronis	K9301628A	EUDAMEDFDA UDI	Class IIa	Active
Barco	991932204032	EUDAMEDFDA UDI	Class I	Active
Barco	K9352022	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303097A	EUDAMEDFDA UDI	Class I	Active
Barco	991932204035	EUDAMED	Class I	Active
Nexxis OR	K9303321B	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320CMS	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303321G	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356050A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303321F	EUDAMEDFDA UDI	Class I	Active
Barco	991932209061	EUDAMEDFDA UDI	Class I	Active
Barco	K9307952	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303310G	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303331X	EUDAMEDFDA UDI	Class I	Active
Barco	K9352051B	EUDAMEDFDA UDI	Class I	Active
Eonis	K9301820ABR	EUDAMEDFDA UDI	Class I	Active
Coronis	K9301636A	EUDAMEDFDA UDI	Class IIa	Active
Barco	K930793302B	EUDAMEDFDA UDI	Class I	Active
Eonis 3D	K9301153A2X	EUDAMED	Class I	Active
Nexxis OR	K9303330	EUDAMEDFDA UDI	Class I	Active
Barco	K9352390	EUDAMEDFDA UDI	Class I	Active
Barco	K9352421	EUDAMEDFDA UDI	Class I	Active
Barco	K9307960	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350201F	EUDAMEDFDA UDI	Class I	Active
Nio	K9300394A1X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9352185	EUDAMEDFDA UDI	Class I	Active
Coronis Uniti	K9301680A	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303301B	EUDAMEDFDA UDI	Class I	Active
Steris	RLM324KMINI	EUDAMEDFDA UDI	Class I	Active
Barco	K9300381A2X	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300360A	EUDAMEDFDA UDI	Class IIa	Active
Eonis	K9307943	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303212	EUDAMEDFDA UDI	Class I	Active
Barco	991932204034	EUDAMED	Class I	Active
Barco	K9308260	EUDAMEDFDA UDI	Class IIa	Active
Eonis	K9307947BR	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303026A	EUDAMEDFDA UDI	Class I	Active
Barco	K9307961	EUDAMEDFDA UDI	Class I	Active
Nio	K9301130A2X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303331	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303301	EUDAMEDFDA UDI	Class I	Active
Eonis	K9301821A	EUDAMEDFDA UDI	Class I	Active
Barco	K9307951	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350216	EUDAMEDFDA UDI	Class I	Active

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