GALVEX, spol. s r.o.

Galvex, spol. s r.o. manufactures over-the-counter topical and oral pharmaceutical preparations classified as Class I medical devices. These include burow’s solution-based products like eye drops (such as BUROW Oordruppels and Ušné kvapky Burow) and ointments (like BuroVax). These devices are designed for local use in minor skin irritations and eye care applications, adhering to the regulatory framework of the Slovak Republic.

Galvex, spol. s r.o. is based in Slovakia (SK). Its devices operate under the regulatory framework of the Slovak Republic, where they are authorised for distribution. While the company’s products are listed in the EU’s eudamed database, their primary regulatory oversight remains within Slovakia’s Ministry of Health.

Yes, Galvex’s Class I medical devices are registered in the EU’s eudamed database. This registry is the official EU-wide system for tracking medical devices, ensuring transparency and compliance with EU medical device regulations. Listing in eudamed confirms the devices meet EU requirements for classification and registration.

Galvex’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products, such as topical ointments, creams, and eye drops, which pose minimal risk to patients. Class I devices typically require less stringent regulatory scrutiny but must still comply with essential safety and performance requirements to ensure their safety and efficacy.