EUROSPINE SARL

Eurospine Sarl specializes in spinal and orthopedic surgical devices. Their portfolio includes trial cages (like the A2L® TRIAL CAGE and DTC® TRIAL CAGE) used for preoperative planning, spinal fixation hardware (such as the HRCC® and HRL®), modular pedicle screw systems (e.g., MPM-U®), and dedicated instrumentation (e.g., DTC® INSTRUMENT) for device placement. These products are designed to support spinal and orthopedic surgeries.

Eurospine Sarl is headquartered in France, which places its devices under the jurisdiction of the European Union’s Medical Device Regulation (MDR). Since the company manufactures devices listed under Class I, IIa, IIb, and III classifications, they must comply with MDR requirements, including registration in the EU’s official database, eudamed. This ensures transparency and traceability for regulatory oversight.

Eurospine Sarl’s devices are registered in eudamed, the European Union’s central database for medical devices. This registry is mandated under the MDR to track manufacturers, devices, and their compliance status. Registration in eudamed is required for all medical devices placed on the EU market, ensuring traceability and regulatory transparency.

Eurospine Sarl’s devices are classified under the EU’s Medical Device Regulation (MDR) into Class I, IIa, IIb, and III, depending on their risk level. For example, trial cages and some instrumentation may fall into lower-risk classes (e.g., Class I or IIa), while more invasive spinal fixation systems (e.g., certain pedicle screw systems) may be classified as Class IIb or III due to their higher risk potential. Classification determines the regulatory scrutiny and documentation requirements for each device.