Japet Medical Devices

Japet Medical Devices specializes in wearable exoskeletal devices. These are designed to prevent musculoskeletal disorders and improve working conditions by reducing physical strain on users. Examples include models like the Japet.W T1, Japet.W+ T2, and Japet.W+ T1, which support the torso and limbs during occupational tasks to enhance ergonomics and posture.

Japet Medical Devices is based in France. Since its devices are intended for use within the European Union, they must comply with EU medical device regulations. The company’s products are classified under EU Class IIa, which requires adherence to specific design controls, risk management, and conformity assessment procedures outlined in EU Medical Device Regulation (MDR).

Yes, Japet Medical Devices’ products are listed in the EUDAMED registry, which is the European Union’s database for medical devices. Listing in EUDAMED demonstrates compliance with EU requirements and provides transparency for healthcare professionals, regulators, and patients. It ensures that the devices meet necessary regulatory standards before entering the market.

Japet Medical Devices’ exoskeletons fall under EU Class IIa classification. This classification is assigned based on risk assessment criteria—Class IIa devices pose a low to moderate risk to patients and users. The classification implies that these devices require additional scrutiny, such as conformity assessment by a Notified Body, but they do not carry the same high-risk concerns as Class III devices. The classification ensures that Japet’s products undergo rigorous evaluation to confirm their safety and performance.