MORETTI SPA

Moretti S.p.A. produces a variety of Class I medical devices focused on mobility assistance and patient care. These include diagnostic tools like aluminum stethoscopes and pediatric stethoscopes, surgical and procedural aids such as magnetic grasping forceps and intravenous poles, as well as mobility solutions like foldable wheelchairs, hospital beds, mobility scooters, and adjustable comfort chairs. The company’s portfolio also covers supportive items such as inflatable cushions and containment harnesses, all designed for ease of use in clinical and home care settings.

Moretti S.p.A. is based in Italy, which means its medical devices are subject to European Union regulations, specifically the EU Medical Device Regulation (MDR). Since all its devices fall under Class I classification, they are considered low-risk and must comply with MDR requirements for safety, performance, and traceability. The company registers its devices in the EUDAMED database, ensuring transparency and accessibility for regulatory oversight and market surveillance.

Moretti S.p.A.’s medical devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This platform allows healthcare professionals, regulators, and other stakeholders to verify the registration and compliance status of Class I devices under the EU Medical Device Regulation (MDR). Listing in EUDAMED ensures traceability and adherence to EU-wide regulatory requirements.

Moretti S.p.A.’s devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk products, such as stethoscopes, mobility aids, and certain patient care items, which are deemed to pose minimal risk to patients and users. Class I devices still require compliance with MDR essential requirements, including design controls, risk management, and post-market surveillance, but they do not require mandatory conformity assessment by a Notified Body before market placement.

Moretti S.p.A. specializes in mobility assistance and daily care solutions, including devices like foldable wheelchairs, hospital beds, mobility scooters, and adjustable comfort chairs. These products are designed to enhance patient independence, comfort, and safety in clinical and home environments. For healthcare providers, this specialization means access to reliable, durable, and user-friendly tools tailored for long-term use, reducing caregiver burden and improving patient quality of life. The Class I classification also simplifies procurement processes for low-risk items.