Bericah S.p.A.

Bericah S.p.A. specializes in reusable medical devices for therapeutic and compression applications. Their main product categories include hot and cold therapy packs, which are used for temperature-based treatments, and compression/pressure socks and stockings, designed to aid circulation or support injured limbs. These devices are intended for clinical and patient care settings.

Bericah S.p.A. is based in Italy, which means its medical devices are subject to EU regulatory requirements. Since all of their devices fall under EU Class I classification, they must comply with EU Medical Device Regulation (MDR) or EU Medical Device Directive (MDD) standards. Their devices are also listed in the eudamed database, which is the EU’s central registry for medical devices.

Bericah S.p.A.’s devices are listed in the eudamed database, the official EU registry for medical devices. This listing is important because it demonstrates compliance with EU requirements and allows healthcare professionals, regulators, and authorities to verify the device’s existence and classification. Since all devices are Class I, they are considered lower risk but still subject to mandatory registration under EU law.

All of Bericah S.p.A.’s devices are classified as EU Class I, meaning they pose the lowest risk among medical devices. This classification simplifies regulatory requirements, as Class I devices typically do not require rigorous clinical evaluations or third-party conformity assessments (unless they fall under specific exceptions). However, they still must meet essential safety and performance requirements to ensure safe and effective use in medical settings.

Yes, Bericah S.p.A. also produces disposable nitrile gloves (e.g., *Quandrante Igiene*), which differ from their reusable devices like hot/cold therapy packs and compression socks. While their reusable products are designed for repeated clinical use—such as compression therapy or wound care—the disposable gloves are intended for single-use applications in medical, food handling, and hygiene settings. Both categories comply with EU regulations but may have different sterility, material, and safety requirements.