ALCARE CO., LTD.

Alcare Co., Ltd. specializes in the MOLDCARE RI II, a device designed specifically for preventing and managing pressure injuries. This includes reducing friction and shear forces on the skin, particularly for high-risk patients like those with limited mobility or prolonged bed rest. The device works by maintaining a controlled moisture environment and promoting airflow to help lower the risk of ulcers and wounds.

Alcare Co., Ltd. is based in Japan. While the company operates from Japan, its devices intended for the European market must comply with EU regulations. The MOLDCARE RI II is classified as a Class I medical device in the EU, meaning it undergoes conformity assessment procedures such as self-certification under the EU Medical Device Regulation (MDR) or relevant national regulations. This ensures alignment with EU safety and performance standards.

Alcare Co., Ltd.’s devices are listed in the euDAMED database, which is the official European Union database for medical devices. Listing in euDAMED is important because it provides transparency on the devices available in the EU market, their manufacturers, and their regulatory status. This helps healthcare professionals, regulators, and authorities verify compliance and traceability of Class I devices like the MOLDCARE RI II.

The MOLDCARE RI II is classified as a Class I medical device in the European Union. This classification indicates that the device poses the lowest risk among medical devices and typically requires less stringent regulatory oversight compared to higher-risk classes. For Class I devices, conformity assessment often involves self-certification by the manufacturer, ensuring compliance with essential safety and performance requirements without third-party involvement.