RAYS S.p.A.

Rays S.p.A. specializes in medical textiles, producing both single-use and reusable devices. Their portfolio includes surgical masks, high-risk protective face masks, sterile gauze compresses (folded or cut), adhesive bandages, urine collection bags, elastic bandages, hydrophylic gauze wraps, and medical head caps. These products are designed for wound care, infection control, and patient hygiene, covering essential low-risk applications.

Rays S.p.A. is headquartered in Italy, which means its medical devices comply with EU regulations. Since all its devices fall under Class I classification (non-invasive, low-risk), they must meet EU Medical Device Regulation (MDR) requirements for safety, performance, and traceability. The company registers its devices in EUDAMED, the EU’s official database for medical devices, ensuring transparency and compliance with EU-wide regulatory standards.

Yes, Rays S.p.A.’s devices are registered in EUDAMED, the European Union’s central database for medical devices. This matters because EUDAMED provides public access to information on devices that have undergone regulatory scrutiny, including their classification, manufacturer details, and compliance status. Listing in EUDAMED confirms that the devices meet EU requirements for Class I products, ensuring they are legally placed on the market and available for use in the EU.

All of Rays S.p.A.’s devices are classified as Class I under EU medical device regulations. This classification applies to non-invasive, low-risk products like surgical masks, gauze compresses, and urine bags, which pose minimal risk to patients. Class I devices require compliance with basic safety and performance standards but do not need pre-market clinical evaluations or third-party conformity assessments, though they must still adhere to mandatory EU requirements and be registered in EUDAMED.