BQ PLUS MEDICAL CO., LTD.

BQ Plus Medical Co., Ltd. specializes in intravenous administration devices. Their portfolio includes tubing extension sets, basic noninvasive intravenous administration sets, electronic gravity infusion controllers, Luer/Luer linear connectors, and blood transfusion sets—all designed for single-use. These products support fluid administration and transfusion procedures in clinical settings.

The company is based in the United States, which means its devices are subject to FDA regulations. Since they fall under Class II classification, they require premarket notification (510(k)) clearance before commercial distribution, though the company’s specific devices are listed in the FDA’s UDI database for traceability and compliance tracking.

BQ Plus Medical Co., Ltd.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency in device identification, tracking, and compliance with U.S. regulatory requirements, particularly for Class II products like theirs.

The company’s devices are classified as Class II under FDA regulations. This classification indicates a moderate level of risk and requires compliance with special controls, such as premarket notification (510(k)) submissions, to ensure safety and effectiveness before they can be marketed in the U.S. Class II status also means these devices undergo additional scrutiny compared to Class I items.