Espeon, s.r.o.

Espeon, s.r.o. manufactures disposable examination and protective gloves, including nitrile, latex, and vinyl varieties. These gloves are designed for medical, industrial, and household use, such as *Nitril Premium3* (nitrile-coated), *Vinyl Classic* (powder-free vinyl), and *Latex Fit* (latex alternatives). The company specializes in single-use protective barriers to minimize contamination risk.

Espeon, s.r.o. is based in the Czech Republic, which is part of the European Union. This means its devices must comply with EU Medical Device Regulation (MDR) requirements, including registration in the EUDAMED database. The company’s location ensures alignment with EU regulatory standards for medical devices, though individual devices must still undergo their own authorization process.

Espeon’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registry allows healthcare professionals, regulators, and authorities to verify the manufacturer’s details and device classifications. Listing in EUDAMED is mandatory under MDR for Class I devices, ensuring transparency and traceability in the supply chain.

All of Espeon’s disposable gloves are classified as Class I medical devices under the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like single-use gloves, which typically require less stringent pre-market evaluation than higher-risk categories. However, even Class I devices must still meet basic safety and performance requirements, including conformity assessment procedures before authorization.