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	K9352310	EUDAMEDFDA UDI	Class I	Active
Barco	K9307918	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303052A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9350201G	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303275A	EUDAMEDFDA UDI	Class I	Active
Barco	K9308254	EUDAMEDFDA UDI	Class IIa	Active
Barco	K930793302	EUDAMEDFDA UDI	Class I	Active
Nio	K9300332B	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303165A	EUDAMEDFDA UDI	Class I	Active
Barco	K9352370	EUDAMEDFDA UDI	Class I	Active
Barco	600301479	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356030A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303054A	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356043A1X	EUDAMEDFDA UDI	Class I	Active
Eonis	K9350030	EUDAMEDFDA UDI	Class I	Active
Barco	K9301636B2X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9307941	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307944BR	EUDAMEDFDA UDI	Class I	Active
Nio	K9300341B	EUDAMEDFDA UDI	Class IIa	Active
Barco	K930793002	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356053A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303099A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303077A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303320G	EUDAMEDFDA UDI	Class I	Active
Eonis	K9356040A1X	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307945	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303321X	EUDAMEDFDA UDI	Class I	Active
Barco	K9300360C1X	EUDAMEDFDA UDI	Class IIa	Active
Coronis	K9301636B1X	EUDAMEDFDA UDI	Class IIa	Active
Nexxis OR	K9303311I	EUDAMEDFDA UDI	Class I	Active
Nio	K9300330B	EUDAMEDFDA UDI	Class IIa	Active
Eonis	K9356034A1X	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303143A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303310	EUDAMEDFDA UDI	Class I	Active
Nio	K9300342B	EUDAMEDFDA UDI	Class IIa	Active
Nio	K9300390A1X	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9350450	EUDAMEDFDA UDI	Class I	Active
Barco	991932209081	EUDAMEDFDA UDI	Class I	Active
Barco	K9352532	EUDAMED	Class I	Active
Nexxis OR	K9303144A	EUDAMEDFDA UDI	Class I	Active
Steris	RLM324KBSND	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303086A	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303311	EUDAMEDFDA UDI	Class I	Active
Nexxis OR	K9303310X	EUDAMEDFDA UDI	Class I	Active
Eonis 32”	K9350830B2X	EUDAMED	Class I	Active
Nexxis OR	K9350201X	EUDAMEDFDA UDI	Class I	Active
Eonis	K9307942	EUDAMEDFDA UDI	Class I	Active
Nio	K9300347B	EUDAMEDFDA UDI	Class IIa	Active
Barco	K9352370B	EUDAMED	Class I	Active
Nexxis OR	K9303311F	EUDAMEDFDA UDI	Class I	Active

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