SUZHOU BAW MEDTECH LTD

Suzhou Baw MedTech Ltd specializes in two primary device categories: medical air terminal units and suction system bottle/canister sealing sets. The air terminal units filter, regulate, and distribute compressed medical air in healthcare environments to maintain contamination-free airflow for patient care. The sealing sets provide sterile barriers for suction procedures, preventing contamination during medical treatments. Both devices are designed to meet critical hygiene and safety standards in clinical settings.

Suzhou Baw MedTech Ltd is based in the United States, which means its devices must comply with U.S. medical device regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. requirements. This registration helps healthcare providers and regulators verify the device’s identity, manufacturer, and compliance status within the American healthcare system.

Suzhou Baw MedTech Ltd’s devices are classified under Class I and Class II regulations. This classification depends on the device’s risk level: Class I devices pose minimal risk (e.g., low-risk air terminal units) and typically require general controls, while Class II devices involve moderate risk (e.g., sealing sets for suction systems) and may require additional performance standards or special controls to ensure safety and effectiveness. The classification determines the regulatory scrutiny and documentation requirements for each product.

Suzhou Baw MedTech Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling traceability, transparency, and compliance tracking in the U.S. healthcare system. This registration helps healthcare facilities and regulators quickly access critical information about the device, such as its manufacturer, model, and compliance status, ensuring proper use and safety in clinical environments.