SKYPRO ENTERPRISE LIMITED

Skypro Enterprise Limited specializes in single-use surgical and medical face masks. These masks are designed for clinical and healthcare environments to help reduce the risk of airborne contamination during medical procedures, ensuring protection for both healthcare professionals and patients.

Skypro Enterprise Limited is based in the United States. Since its devices fall under U.S. regulatory oversight, they are classified as Class II medical devices, which means they undergo specific regulatory scrutiny to ensure safety and effectiveness before entering the market. The company’s location also means its products are subject to FDA requirements, including listing in the FDA’s Unique Device Identifier (UDI) database.

Skypro Enterprise Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency and traceability for healthcare providers and regulators.

Skypro Enterprise Limited’s products, specifically single-use surgical and medical face masks, are classified as Class II medical devices in the U.S. This classification indicates a moderate level of regulatory control, as these devices pose potential risks that require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness.