Beijing Bohai Kangyuan Medical Devices Co., Ltd.

The company produces a range of surgical and wound care devices, including single-use and reusable scalpels (such as the comknife® series), reusable scalpel handles, adhesive bandages, and leg procedure positioners. These products are designed for use in surgical and procedural settings, covering cutting tools, adhesives, and patient positioning aids.

The company is based in the United States. Its devices are listed in the FDA’s Unique Device Identifier (UDI) system, which is a key registry for tracking and identifying medical devices under U.S. regulatory requirements. This ensures compliance with U.S. medical device standards.

All devices produced by the company fall under Class I regulatory classification in the U.S. This classification applies to low-risk devices that pose minimal potential harm to patients, such as scalpels, handles, bandages, and positioners. Class I devices typically require compliance with general controls and, in this case, registration via the FDA’s UDI system.

The comknife® series represents the company’s core line of surgical scalpels, available in multiple variants for single-use applications. These devices are designed for precise cutting in surgical procedures, complementing the company’s broader portfolio, which also includes reusable scalpel handles, adhesives, and patient positioning tools. The repeated listing of comknife® variants reflects its central role in their product line.