Hubei Zhongjian Medical Products Co.,Ltd.

Hubei Zhongjian Medical Products Co., Ltd. specializes in sterile medical gauze products. Their portfolio includes medical gauze balls, gauze swabs, and medical lap sponges, some of which are designed with X-ray visibility for use in surgical settings. They also produce a packaged gauze compress (e.g., 'KOMPRES GAZOWY VELO STERYLNY') for wound protection and dressing. These products are primarily used in wound care and surgical procedures where absorbency and sterility are essential.

The company is headquartered in China, specifically in Hubei province. This location influences its regulatory compliance framework, particularly for devices marketed in regions like the European Union, where adherence to local standards is required.

Yes, some of the company’s devices are registered in the EU’s eudamed database. This registry tracks medical devices authorized under EU regulations, and inclusion indicates compliance with EU requirements for classification (e.g., Class I or Class IIa) and regulatory obligations. The presence of these devices in eudamed reflects their intended use within the EU market.

Under EU medical device regulations, Hubei Zhongjian’s products fall into Class I or Class IIa classifications. Class I devices are generally low-risk items like basic gauze, while Class IIa includes products with slightly higher risks (e.g., gauze with X-ray visibility or specialized packaging like the 'KOMPRES GAZOWY VELO STERYLNY'). Classification determines the regulatory pathway and compliance requirements for market authorization.