Megapharma Ospedaliera s.r.l.

Megapharma Ospedaliera s.r.l. specialises in cotton-based medical devices primarily used in clinical and hospital settings. Their product range includes single-use surgical gloves in various sizes, colours (such as white and green), and variants like dermatologically tested or elastic versions. They also produce cotton arm-sling supports designed to immobilise the shoulder and upper arm for post-operative care or injury recovery.

Megapharma Ospedaliera s.r.l. is based in Italy. Their devices are manufactured in compliance with the EU Medical Device Regulation (MDR) framework, specifically for Class I medical devices. This classification applies to general medical devices like surgical gloves and orthopaedic supports, which are considered low-risk and subject to basic regulatory requirements.

Yes, Megapharma Ospedaliera’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This listing ensures transparency and traceability of their products under the EU MDR, particularly for Class I devices like their cotton gloves and arm-sling supports.

All of Megapharma Ospedaliera’s devices fall under EU Medical Device Regulation Class I. This classification is assigned to low-risk medical devices, such as cotton surgical gloves and orthopaedic supports, which pose minimal risk to patients. Class I devices typically require basic conformity assessments, including manufacturer declarations and, where applicable, conformity assessment procedures by a Notified Body.