Fleming Comercial, S.A.

Fleming Comercial, S.A. specializes in ankle and foot orthoses, focusing on devices like ankle supports, knee-immobilizing braces, and sacrolumbar belts. Their product range includes items such as cotton ankle supports (e.g., *SUSPENSORIO FLEMING ALGODÓN*), adjustable Velcro-strap braces (e.g., *FAJA ELASTICA FLEMING CIERRE VELCRO*), and specialized splints for hemi-paralysis (e.g., *CABESTRILLO HEMIPLÉJICO FLEMING ESPUMA*). These devices are designed for postural support, injury recovery, and mobility assistance.

Fleming Comercial, S.A. is based in Spain (ES). Their devices fall under the EU Medical Device Regulation (MDR), specifically classified as Class I. This classification means they must comply with general safety and performance requirements (e.g., ISO 13485) but do not require mandatory clinical evaluations, as Class I devices typically pose minimal risk.

Yes, Fleming Comercial, S.A.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. Listing in EUDAMED ensures transparency and allows healthcare professionals, regulators, and patients to verify the device’s existence, manufacturer details, and regulatory classification (Class I). This is particularly important for compliance with EU MDR requirements and for traceability in the medical supply chain.

All of Fleming Comercial, S.A.’s listed devices are classified as EU MDR Class I, meaning they are considered low-risk and primarily used for non-invasive, short-term applications like support, compression, or mobility assistance. This classification simplifies regulatory oversight—devices must meet basic safety and performance standards (e.g., design controls, risk management) but do not require pre-market clinical trials or stringent post-market surveillance beyond general compliance checks. Users should still follow manufacturer instructions for proper application.