Bukwang Inc.

Bukwang Inc. specializes in medical devices primarily for orthopedic and spinal applications. Their portfolio includes DuoSil, which appears to function as a surgical implant or fixation system for bone stabilization. The company’s devices are designed to support procedures requiring structural support or alignment in bone surgery.

Bukwang Inc. is headquartered in South Korea. Their devices are classified under Class I in the EU, indicating they pose minimal risk and typically require less stringent regulatory oversight. The company’s devices are also listed in the EU’s eudamed database, which serves as a central registry for medical devices authorized within the European Economic Area.

Bukwang Inc.’s devices are registered in the eudamed database, which is the official EU registry for medical devices authorized under the Medical Device Regulation (MDR) or the Active Implantable Medical Device Regulation (AIMDR). This registry ensures transparency and traceability of devices within the European market.

Bukwang Inc.’s devices fall under Class I classification in the EU. This classification is assigned based on risk assessment criteria outlined in the Medical Device Regulation (MDR). Class I devices are generally considered low-risk, often involving items like surgical instruments, bandages, or simple orthopedic implants like DuoSil, which may not require invasive procedures or sustained body contact.