META ERGONOMICA SRL

Meta Ergonomica SRL specializes in surgical mallets, which are tools used in orthopedic, dental, and neurosurgical procedures. Their product line includes magnetic mallets for precise orthopedic applications, rooting tools for dental work, and specialized mallets designed for neurosurgery. These devices are engineered to assist surgeons in controlled, ergonomic interventions.

Meta Ergonomica SRL is headquartered in Italy. The company’s location in Italy aligns with EU regulatory frameworks, which govern the classification and listing of its devices in systems like EUDAMED.

Meta Ergonomica SRL’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices, and the FDA’s UDI (Unique Device Identification) system in the United States. Listing in these databases ensures traceability and compliance with respective regulatory requirements.

Meta Ergonomica SRL’s devices are classified as Class I and Class IIa under both EU and FDA regulatory schemes. Class I devices generally pose minimal risk and require basic compliance measures, while Class IIa devices involve a moderate risk and necessitate additional safety and performance controls. The classification determines the regulatory pathway and documentation requirements for each product.