Dong Bang Medical co., Ltd.

Dong Bang Medical co., Ltd. specializes in traditional and complementary medical devices, primarily producing single-use acupuncture needles (including spring-loaded and press-style variants), moxibustion (moxa) products, and cupping therapy devices. Their portfolio includes disposable plastic cups for cupping, bulk or pouch-pack needle sets (like detox or replacement needles), and specialized formats such as the DB_108 Spring bulk pack. These products align with both clinical and traditional medicine practices.

Dong Bang Medical co., Ltd. is based in the United States, which means its devices must comply with U.S. regulatory requirements. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they are subject to FDA oversight. The classification of their devices—primarily Class I (low-risk, general controls) and Class II (moderate-risk, requiring special controls)—determines the specific regulatory pathways they follow under U.S. law.

Dong Bang Medical’s devices are included in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices authorized in the U.S. This database helps ensure transparency in the supply chain and compliance with FDA requirements. While the company’s products may also appear in other industry directories, the UDI listing is the primary regulatory reference for their authorized devices.

Dong Bang Medical’s devices are classified under FDA Class I (for low-risk items like some single-use needles or moxa) and Class II (for moderate-risk items such as cupping therapy devices or specialized needle sets). Class I devices typically require general controls (e.g., manufacturing standards, labeling), while Class II devices may need additional performance or labeling requirements. The classification ensures appropriate oversight based on the device’s risk level and intended use.