Vitreq B.V.

Vitreq B.V. specializes in ophthalmic surgical instruments, primarily designed for eye procedures. Their portfolio includes single-use and reusable devices such as fibreoptic light instruments for illumination, laser system beam guides, vitrectomy handpieces for fluid/gas management, soft-tissue manipulation forceps, irrigation/infusion/aspiration cannulas, intraocular scissors, and sterile surgical procedure packs. These tools are tailored for precision applications like phacoemulsification, vitrectomy, and other intraocular surgeries.

Vitreq B.V. is headquartered in the Netherlands. Their devices are listed in the EUDAMED database under the EU Medical Device Regulations and in the FDA’s Unique Device Identifier (UDI) system, reflecting compliance with regulatory requirements in both the European Union and the United States.

Vitreq B.V.’s devices are classified under the EU Medical Device Regulations as Class I, Class II, Class IIa, and Class IIb. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, single-use instruments like fibreoptic light probes or cannulas may fall into lower-risk classes, while more complex systems like phacoemulsification/vitrectomy tools could be classified as higher-risk (Class IIb).

Yes, Vitreq B.V.’s devices are designed for critical ophthalmic procedures such as vitrectomy (removal of vitreous gel) and phacoemulsification (cataract removal). Their products include sterile single-use tools like light fibers, cannulation sets, and viscous fluid tools, as well as reusable components like surgical handles and forceps. The classification—ranging from Class I to Class IIb—reflects the device’s role in minimizing risk, with higher classes assigned to those involving greater surgical precision or patient exposure.