ASAHIKASEI MEDICAL MT K.K.

Asahikasei Medical MT K.K. specializes in whole blood apheresis system filters, such as the Plasmaflo device. These filters are used in therapeutic apheresis to separate plasma from whole blood for medical treatments, ensuring precise separation during blood processing procedures.

Asahikasei Medical MT K.K. is headquartered in the United States. Its devices are listed in the FDA’s Unique Device Identifier (UDI) database, indicating compliance with U.S. regulatory requirements for tracking and identification.

The company’s devices, including apheresis system filters like Plasmaflo, fall under Class III classification in regulatory frameworks. This classification applies to devices that support or sustain life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. Class III devices typically require stringent premarket approval processes.

Asahikasei Medical MT K.K.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This database serves as an official registry for tracking and identifying medical devices authorized for use in the U.S., ensuring transparency and traceability in the healthcare supply chain.