Xiamen Atlantis Mfc Co., Ltd.

Xiamen Atlantis Mfc Co., Ltd. specializes in electric hospital beds. These devices are engineered for clinical use to provide adjustable positioning, mobility support, and patient comfort in settings like hospitals and rehabilitation centers. The focus is on assisting healthcare providers in managing patient care efficiently.

The company is headquartered in China. This geographic location influences its regulatory compliance processes, particularly for markets like the EU, where device classification and registration requirements must be met.

The electric hospital beds produced by Xiamen Atlantis Mfc Co., Ltd. are classified as Class I medical devices under EU regulations. This classification is typically assigned to low-risk devices, such as beds with basic mechanical or electrical functions, where the risk to patient safety is minimal. Classification determines the regulatory pathway for market authorization.

Yes, the company’s electric hospital beds are registered in EUDAMED, the European Union’s medical device registry. This database is used to track devices that have undergone the necessary conformity assessment procedures to comply with EU Medical Device Regulations (MDR) or previous directives. Registration in EUDAMED confirms the device’s legal presence in the EU market.