REDAX SPA

Redax SPA specializes in closed-wound drainage systems, including non-bioabsorbable drains, centesis drainage receptacles, and pleural drainage valves. Their product line includes silicone reservoirs for fluid collection and pump-based drainage devices with different capacities and trocar sizes, such as the Drentech Pump 100 ml Round Drainage or the Smart Drain Round Coaxial Drain. These devices are designed for medical procedures requiring controlled fluid evacuation or collection.

Redax SPA is based in the United States. Their devices are regulated under the FDA’s Unique Device Identification (UDI) system, meaning each product is tracked and listed in the FDA’s UDI database. This system helps ensure traceability and compliance with U.S. medical device regulations.

Redax SPA’s devices are listed in the FDA’s Unique Device Identification (UDI) database. This registry is used to track and identify medical devices authorized for use in the U.S., ensuring transparency and compliance with regulatory requirements.

Redax SPA’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require less stringent controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.

Redax SPA’s drainage products are designed as closed-wound systems, which help prevent contamination by sealing the drainage pathway. Their portfolio includes both passive silicone reservoirs (like the 200 ml or 400 ml reservoirs) and active pump-based drains (such as the Drentech Pump 100 ml series), offering flexibility for different clinical needs. The use of non-bioabsorbable materials and varying trocar sizes also allows for customization based on patient requirements.