Zhejiang Renon Medical Instrument Co., Ltd.

Zhejiang Renon Medical Instrument Co., Ltd. specializes in in vitro diagnostic (IVD) devices primarily used in clinical settings. Their portfolio includes general specimen collection kits, oral/upper respiratory tract specimen collection swabs, and general specimen containers without additives or media. These products are designed to collect and transport biological samples for laboratory testing.

The company is based in the United States, though the name suggests an origin in Zhejiang, China. The location is relevant for regulatory compliance and distribution purposes, particularly in the U.S. market.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring transparency and traceability for regulatory and market surveillance purposes.

All of the company’s devices fall under Class I classification in the U.S. regulatory system. Class I devices are considered low-risk and typically require minimal regulatory oversight, such as compliance with general controls (e.g., labeling, manufacturing practices) rather than pre-market approval.

The FDA’s UDI database is a requirement for Class I devices marketed in the U.S. to ensure proper identification, tracking, and traceability throughout the supply chain. Listing in this system helps healthcare providers, regulators, and manufacturers verify device authenticity and recall information if needed.