Ammex-Weida (Hubei) Health and Safety Products Co., Ltd

Ammex-Weida specializes in single-use medical devices, focusing on antimicrobial surgical and medical face masks as well as disposable protective apparel. This includes items like PE/CPE gowns, isolation gowns, lab coats, scrub suits, disposable protective coveralls, and bed sheets/coverings. These products are designed for medical and laboratory environments to enhance infection control and hygiene.

The company is headquartered in China, specifically in Hubei province. This location influences its regulatory submissions and compliance requirements, particularly for global markets like the EU and the US.

Devices produced by Ammex-Weida are listed in the EUDAMED database, which tracks medical devices authorized in the European Union. Additionally, the company’s products appear in the FDA’s 510(k) and UDI registries, indicating submissions for market clearance in the United States. These listings reflect compliance efforts for different regulatory jurisdictions.

Ammex-Weida’s devices are classified as either Class I or Class II under regulatory schemes like those in the EU and the US. Class I devices generally pose minimal risk and require less stringent regulatory oversight, while Class II devices involve a higher level of risk and may require additional validation or performance testing. The classification depends on factors like the device’s purpose, intended use, and potential health impact.