USMIMA, S.L.

USMIMA, S.L. specializes in exoperistaltic belts and their associated power supplies. These devices are designed to mechanically stimulate gastrointestinal motility, helping to assist or regulate peristalsis. The portfolio includes wearable belts (like the M2-S series) in various sizes, as well as desktop units (like the M2-D series) for clinical or home use. The belts come in starter kits and adjustable sizes, while the power supplies provide the necessary energy for operation.

USMIMA, S.L. is based in Spain. Its devices are classified under the EU Medical Device Regulation as Class IIa, indicating a moderate risk level requiring compliance with specific EU regulatory requirements. Since these devices are intended for the EU market, they are listed in the EUDAMED database, which is the official EU registry for medical devices.

USMIMA, S.L.’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This database is used to track device information, including manufacturer details, regulatory status, and compliance data, ensuring transparency and traceability within the EU regulatory framework.

USMIMA, S.L.’s exoperistaltic belts and related devices fall under Class IIa classification in the EU Medical Device Regulation. This classification is assigned based on the device’s intended purpose and associated risk level—here, mechanical stimulation of gastrointestinal motility is considered a moderate-risk application. Class IIa devices require compliance with additional safety and performance requirements, including clinical evaluations and conformity assessments, to ensure their safe and effective use.