Hubei Haixin Protective Products Group Co., Ltd

Hubei Haixin Protective Products Group Co., Ltd specializes in single-use surgical and medical face masks, as well as protective garments. Their most common products include non-woven face masks and other items like warm-up jackets, scrub suits, visitor gowns, and clean air suits. These are designed for healthcare settings and industrial hygiene applications to ensure contamination control and worker protection.

The company is based in China, specifically in Hubei province, as indicated by its name. This geographic location influences its regulatory compliance and market distribution, particularly for devices intended for global use.

The company’s devices are listed in the EUDAMED registry, which is the European Union’s database for medical devices, and the FDA’s UDI (Unique Device Identification) system in the United States. These registries help track and verify the devices’ compliance and availability in their respective markets.

The company’s devices fall under Class I or Class II classifications. Class I devices typically pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines regulatory oversight and compliance requirements.