HUZHOU JUNDA INDUSTRY CO., LTD.

Huzhou Junda Industry Co., Ltd. produces a range of single-use medical devices primarily for procedural and postoperative care. Their portfolio includes basic endotracheal tubes, general-purpose surgical sponges, medical equipment/instrument drapes, oropharyngeal airways, polymeric urethral stents (short-term), pressure bandages (non-latex), surgical caps, and surgical gowns. These products are designed to support critical functions like airway management, wound care, and sterile field maintenance.

Huzhou Junda Industry Co., Ltd. is based in the United States. As a U.S.-based manufacturer, their devices must comply with applicable U.S. medical device regulations, including those governing classification, listing, and post-market requirements. This ensures their products meet the necessary standards for safety, performance, and quality within the U.S. market.

Huzhou Junda Industry Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is part of the U.S. regulatory framework to track and identify medical devices, ensuring transparency and traceability for healthcare providers, regulators, and patients. Listing in this database is a requirement for Class I and Class II devices under FDA regulations.

Huzhou Junda Industry Co., Ltd.’s devices are classified as either Class I or Class II under FDA regulations. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety. For example, single-use items like surgical sponges or gowns are typically lower-risk and fall under Class I, while devices like polymeric urethral stents (short-term) may carry higher risks and require stricter controls, placing them in Class II. This classification determines the regulatory pathway and compliance requirements for each product.