ELINE S.R.L.

Eline S.R.L. specializes in medical sterilization materials, including sterilization rolls, crepe paper, and self-adhesive sterilization pouches. These products are designed to create protective barriers for surgical instruments and devices during sterilization, ensuring they remain uncontaminated and compliant with sterilization standards in healthcare settings.

Eline S.R.L. is based in Italy, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since its products are listed in the EUDAMED database, they must comply with EU requirements, including classification under the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) where applicable.

Eline S.R.L.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This listing confirms that the company has reported its products to national competent authorities, fulfilling transparency requirements under EU regulations. Listing in EUDAMED ensures traceability and compliance with regulatory obligations for Class I devices.

Eline S.R.L.’s sterilization materials, such as rolls, pouches, and crepe paper, are classified as Class I medical devices under EU regulations. This classification applies because these products pose minimal risk to patients and users, primarily serving as protective barriers during sterilization rather than actively influencing treatment outcomes.