ML FUSION

ML Fusion specialises in orthopaedic and examination equipment. Their product range includes adjustable and non-adjustable horizontal presses for weights between 80 kg and 120 kg, designed for frontal or lateral loading. They also produce universal pulleys with dual systems, supporting loads up to 60 kg, and examination tables with two-, three-, and four-plane designs. These tables feature adjustable or reclining backrests, articulated leg supports, and wheeled frames, catering to clinical and rehabilitation settings.

ML Fusion is based in France. Since their devices fall under Class I classification, they must comply with the EU Medical Device Regulation (MDR) requirements. This includes registration in the EUDAMED database, which is the official EU portal for medical device information, ensuring traceability and transparency under MDR.

ML Fusion’s devices are registered in the EUDAMED database, which is the centralised EU system for tracking medical devices under the EU Medical Device Regulation (MDR). This registry ensures visibility and compliance tracking for Class I devices within the European market.

All of ML Fusion’s listed devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk devices, such as examination tables and presses, where the risk to patient safety is minimal. Class I devices still require compliance with MDR requirements, including registration in EUDAMED, but do not require third-party conformity assessment (unless custom-designed or sterile).

ML Fusion’s examination tables and presses are classified as Class I because they pose minimal risk to patient safety. These devices are primarily used for physical therapy, rehabilitation, or clinical assessments and do not involve invasive procedures or high-risk interventions. Under MDR, such low-risk products are exempt from stringent conformity assessment procedures but must still meet essential safety and performance requirements, including proper labeling, risk management, and regulatory registration.