Beijing HangTian KaDi Technology R&D Institute

Beijing HangTian KaDi Technology R&D Institute specializes in surgical instruments and accessories. Their product range includes stabilizers for orthopedic or spinal surgeries, a specimen retrieval bag for handling tissue or implants, a uterine manipulator for gynecological procedures, and a sternal retractor for cardiac or thoracic operations. These devices are designed to assist in precise surgical interventions across different medical specialties.

The company is headquartered in China, specifically in Beijing. This location positions them within a key global market for medical device manufacturing and innovation.

The company’s devices are listed in the EUDAMED database, which tracks medical devices authorized in the European Union, and the FDA’s 510(k) registry, which documents premarket notifications for devices seeking clearance in the United States. These listings reflect compliance with regulatory requirements in those regions.

The devices produced by the company fall under Class I or Class II classifications. Class I devices generally pose minimal risk and may require fewer regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes.