Changzhou Hongtai Paper Film Co., Ltd.

Changzhou Hongtai Paper Film Co., Ltd. specializes in single-use medical textiles. Their primary products include absorbent underpads (non-antimicrobial), adult incontinence nappies, examination and treatment table liners, and disposable patient gowns. These items are designed for short-term clinical and patient care settings where hygiene and disposability are critical.

The company is based in the United States. While the name suggests a Chinese origin, the manufacturing entity listed operates within the U.S. regulatory environment for medical devices.

All of the company’s listed devices fall under Class I regulatory classification in the U.S. This classification applies to low-risk medical devices, where the risk of illness or injury from use is minimal. Authorisation is typically granted through the FDA’s UDI (Unique Device Identification) system, ensuring traceability and compliance without requiring pre-market approval.

Yes, the company’s devices are registered under the FDA’s UDI (Unique Device Identification) system. This registry ensures each product is identifiable and compliant with U.S. medical device regulations, though individual devices—not the company—are authorised for use.