Chen Qian Electronic Commerce (Hangzhou) Co., Ltd.

Chen Qian Electronic Commerce (Hangzhou) Co., Ltd. specializes in two primary device categories: single-use nebulizing system delivery sets, which are designed for direct patient use, and benchtop therapeutic agent nebulizers. These devices are intended for delivering aerosolized medications in clinical or homecare settings, ensuring precise and controlled administration of treatments.

The company is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, this indicates compliance with UDI requirements—a key step in the regulatory process for medical devices in the US. However, regulatory approval or clearance is determined on a per-device basis, not the company itself.

The company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for identifying medical devices in the US, ensuring traceability and compliance with regulatory tracking requirements. Listing in the UDI database is a mandatory step for many Class I and Class II devices to facilitate monitoring and post-market surveillance.

The company’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and scrutiny each device undergoes during authorization.