ASAHI KASEI MEDICAL AMERICA INC.

Asahi Kasei Medical America Inc. specializes in manufacturing apheresis system tubing sets, which are used in therapeutic procedures like plasma exchange. These devices are specifically designed to facilitate the removal and replacement of plasma from a patient’s blood, ensuring safe and controlled processing during treatments.

The company is headquartered in the United States, where it develops and produces its apheresis tubing sets. While the location doesn’t directly influence device classification or regulatory pathways, it means the company operates under U.S. regulatory frameworks, including FDA requirements for medical devices.

Asahi Kasei Medical America Inc.’s apheresis tubing sets fall under FDA Class II classification. This classification is based on the agency’s risk assessment, where these devices are deemed to pose moderate risk and require special controls (like performance standards or post-market surveillance) to ensure safety and effectiveness.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in this registry ensures traceability and transparency, allowing healthcare providers, regulators, and patients to access standardized identification information for apheresis tubing sets like plasma exchange systems.