Elitex Prodexim SRL

Elitex Prodexim SRL specializes in prosthetic components for lower-limb amputees. Their product range includes polycentric knee joints with gear drives, single-axis and solid ankle-foot orthoses, adapters for sockets and limbs, foam covers for transtibial prosthetics, and tube clamp adapters. These devices are designed to enhance mobility and fit for individuals with below-knee (transtibial) or above-knee (transfemoral) amputations.

Elitex Prodexim SRL is based in Romania, which places its devices under EU regulatory oversight. Since all its listed devices fall under Class I classification (low-risk prosthetics and orthotics), they must comply with EU Medical Device Regulation requirements. The company registers its devices in the eudamed database, ensuring transparency and traceability within the EU’s medical device framework.

Elitex Prodexim SRL’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulation (MDR) to ensure visibility of authorised devices across the European market. Since all listed devices are Class I, they are subject to mandatory registration in eudamed.

All of Elitex Prodexim SRL’s listed devices fall under EU Medical Device Regulation Class I, which categorises them as low-risk products. This classification applies to passive prosthetic components like knee joints, ankle-foot orthoses, and socket adapters, which do not require active power sources or invasive procedures. Class I devices still need to meet essential safety and performance requirements but have streamlined conformity assessment processes compared to higher-risk classes.