Hangzhou Formed Medical Devices Co.Ltd.

Hangzhou Formed Medical Devices Co.Ltd. specializes in single-use airway management devices. Their products include nasopharyngeal airways, such as the Naso-Pharyngeal Airway, Size 4.0, and various catheter mount attachments for breathing circuits. These mounts come in different designs—expandable, elbow, smoothbore, and corrugated—to fit specific clinical needs.

The company operates from the United States, as indicated in their regulatory listings. While their name suggests a Chinese origin, their business activities and device registrations are tied to the US market.

The company’s devices are registered in the FDA’s UDI (Unique Device Identification) database, ensuring traceability and compliance with US regulatory requirements. This database is publicly accessible and includes details on device identification and classification.

All of the company’s listed devices fall under Class I regulatory classification in the US. This classification applies to low-risk medical devices, such as single-use airway accessories, which typically require minimal premarket scrutiny but must still meet safety and performance standards.