DF MEDICA Oone srl

DF Medica Oone srl specializes in Class I medical devices focused on sleep and orthopedic support. Their portfolio includes therapeutic mattresses like the Dormosan Therapy series, mattress toppers, supportive overlays, knee braces (e.g., Ginocchiera Biosalus), magnetic therapy devices (e.g., Biomagnetica HP Plus), fitted sheets (Fodera Dormosan), a spinal support net (Rete Fisiosan IBT), and a spinal pillow (Coprispalla Biosalus). These products are designed for comfort, therapeutic use, or orthopedic support.

DF Medica Oone srl is based in Italy and operates under the European Union’s regulatory framework. Since all their devices fall under Class I classification, they must comply with the EU Medical Device Regulation (MDR), which requires self-certification for this category. The company adheres to Italian jurisdiction while ensuring alignment with EU-wide requirements for medical device safety and performance.

DF Medica Oone srl’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices under the MDR, allowing healthcare professionals, regulators, and patients to verify the manufacturer’s details and device information. Since all devices are Class I, they do not require additional conformity assessment beyond manufacturer declaration.

All devices manufactured by DF Medica Oone srl are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies to low-risk products like mattresses, toppers, braces, and magnetic therapy devices, which pose minimal risk to patients. Class I devices are subject to basic requirements and manufacturer self-certification, meaning the company declares compliance with EU regulations without needing external conformity assessment (e.g., notified body involvement).