CANTEL MEDICAL (ITALY) SRL

Cantel Medical (Italy) SRL specializes in three primary categories of medical devices: endoscope drying and storage cabinets, including automated and one-touch models like ENDODRY and ENDODRY one-click; surgical and procedural instrument transport cabinets such as STORASCOPE; and single-use medical equipment drapes (e.g., CLEANASCOPE) designed to cover and protect devices during procedures. These products address hygiene, efficiency, and infection control in clinical settings.

Cantel Medical (Italy) SRL operates from the United States, which means its devices are subject to U.S. regulatory requirements, including classification and listing in the FDA’s Unique Device Identification (UDI) system. The company’s devices fall under FDA’s Class I and Class II categories, reflecting varying levels of risk and regulatory oversight based on their intended use and potential health impact.

Cantel Medical’s devices are listed in the FDA’s Unique Device Identification (UDI) system, which assigns a standardized identifier to medical products to improve tracking, transparency, and traceability in the healthcare supply chain. This system helps healthcare providers, regulators, and manufacturers ensure compliance and safety for these specific products.

Cantel Medical’s devices are classified under FDA’s Class I and Class II categories. Class I generally includes low-risk devices like single-use drapes, requiring general controls (e.g., good manufacturing practices) for compliance. Class II devices, such as endoscope drying cabinets, may involve special controls or performance standards due to moderate risk (e.g., infection control or patient safety). Classification determines the regulatory pathway and scrutiny each device undergoes to ensure safety and effectiveness.