Anshi Medical Group Co., Ltd.

Anshi Medical Group Co., Ltd. specializes in single-use disposable medical devices, specifically disposable surgical gowns and medical face masks. These products are designed to offer barrier protection for healthcare workers and patients during clinical and procedural settings, ensuring hygiene and safety in medical environments.

Anshi Medical Group Co., Ltd. is headquartered in China. The company’s location influences its regulatory compliance and manufacturing processes, particularly for devices intended for global markets like the European Union.

Anshi Medical Group Co., Ltd.’s devices are listed in the eudamed database, which is the EU’s official registry for medical devices under the Medical Device Regulation (MDR). This registration is required for devices marketed within the European Economic Area.

Under the EU Medical Device Regulation (MDR), Anshi Medical Group Co., Ltd.’s disposable surgical gowns and medical face masks are classified as Class I devices. This classification applies because these products pose minimal risk to patients and users, typically requiring only general safety and performance requirements without additional scrutiny.