BEAR Medic Corporation

BEAR Medic Corporation specializes in manufacturing microvascular clips, such as the TKF-2-15C, TKM-1-60C, TKS-1-40C, and the Disposable Microvascular Clip. These devices are designed for surgical procedures requiring precise and secure clamping, particularly in microvascular anastomosis. The portfolio includes various models with different sizes and configurations to suit specific clinical needs.

BEAR Medic Corporation is based in Japan. The company’s microvascular clips, including models like the TKL-2-120C and TKM-2-30C, are manufactured in Japan. The location of manufacturing aligns with regulatory requirements for Class IIa devices, ensuring compliance with applicable standards.

BEAR Medic Corporation’s microvascular clips are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry tracks devices that have undergone the necessary regulatory processes for market placement within the EU, such as conformity assessment procedures for Class IIa devices.

BEAR Medic Corporation’s microvascular clips, including the TKF-1-30C and TKS-2-40C, are classified as Class IIa medical devices. This classification is determined by their intended use in surgical procedures requiring precise clamping, which presents a moderate risk level. Class IIa devices typically require additional scrutiny, such as design verification and risk management, but do not require invasive clinical investigations before market authorization.