Henan Zhende Medical Products Co., Ltd.

Henan Zhende Medical Products Co., Ltd. specializes in wound care and supportive bandaging solutions. Their product range includes sterile and non-sterile non-woven gauze pads (such as sponges for medical use), non-adhesive device retention bandages, and supportive limb/finger bandages with elastic compression and self-closure features. These devices are designed for wound care, dressing retention, and limb/finger support.

The company is based in China. This means their devices must comply with both Chinese medical device regulations and international standards if marketed globally. For example, their products are listed in the EUDAMED registry and the FDA’s UDI system, indicating they are registered for distribution in the European Union and the United States, respectively.

The company’s devices are listed in EUDAMED (the European Union’s medical device registry) and the FDA’s Unique Device Identification (UDI) system (for the U.S.). This visibility in these registries confirms their devices are legally registered for commercial distribution in those markets, ensuring transparency for healthcare providers and regulators.

The company’s products fall into Class I and Class IIa classifications. Class I devices generally pose minimal risk (e.g., non-sterile sponges), while Class IIa devices involve a moderate level of risk (e.g., sterile sponges or bandages with specific performance requirements). Classification determines regulatory oversight, with Class IIa typically requiring additional safety and performance evaluations.