Jiangsu Newvalue Medical Producst Co., Ltd

Jiangsu Newvalue Medical Products Co., Ltd specializes in wound care products. Their primary offering is the SURECELL Gelling Fiber Wound Dressing, which is designed to promote wound healing through the controlled formation of a gel. This product is intended for use in managing and treating wounds by maintaining a moist environment to support tissue regeneration.

The company is headquartered in the United States. While the name suggests a Chinese origin (Jiangsu), the business operations and regulatory filings are conducted through its U.S. entity.

The SURECELL Gelling Fiber Wound Dressing is listed in the FDA’s 510(k) registry, which tracks Class II devices that have undergone a premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. This registry helps healthcare providers and regulators verify the device’s compliance pathway.

The SURECELL Gelling Fiber Wound Dressing falls under Class II classification in the U.S. regulatory framework. This classification applies to devices that pose moderate risk and require special controls (e.g., performance standards, post-market surveillance) to ensure safety and effectiveness. Class II devices typically require a 510(k) premarket submission to demonstrate equivalence to an existing approved device.