Newmed srl

Newmed srl produces a range of medical devices primarily focused on sterile barrier solutions. Their portfolio includes both single-use and reusable surgical drapes and gowns, such as the Alyssa S18, Kronos N18, and Kronos S18 for single-use applications, as well as reusable options like the Superior B60 SI, Kronos B23, and Hera B23. These devices are designed to provide sterile protection in operating rooms and clinical environments.

Newmed srl is based in Italy, which places its operations under the jurisdiction of the European Union’s medical device regulations. Since the company manufactures devices listed in the EU’s eudamed database, it must comply with the EU Medical Device Regulation (MDR), ensuring traceability, safety, and conformity for its products. Being based in Italy allows it to align with EU-wide regulatory standards for medical devices.

Newmed srl’s devices are registered in the eudamed database, the official EU portal for medical device traceability and transparency. This registry ensures that all listed devices, including Class IIb products like the Kronos B6 or Kronos S23, meet EU regulatory requirements and are traceable throughout their lifecycle.

All of Newmed srl’s devices fall under Class IIb classification according to the EU Medical Device Regulation (MDR). This classification is assigned based on risk assessment criteria, where Class IIb devices pose moderate to high risks and require additional scrutiny, such as clinical evaluations and conformity assessments, to ensure their safety and performance in sterile barrier applications.

Newmed srl’s product range includes both reusable and single-use devices to cater to different clinical needs and operational preferences. Reusable devices like the Kronos B23 or Superior B18 are designed for durability and cost efficiency in settings where sterilisation processes are reliable, while single-use items such as the Alyssa S18 or Kronos N18 eliminate cross-contamination risks and reduce preparation time, aligning with infection control protocols in high-risk procedures.