Wosem Co., Ltd.

Wosem Co., Ltd. specializes in medical devices focused on mobility and pressure management. Their portfolio includes a Negative Pressure Carrier, which is likely used for therapeutic applications to reduce pressure on specific body areas, and a Negative Pressure Isolation Wheelchair, designed for clinical environments to manage pressure and isolation needs for patients.

Wosem Co., Ltd. is headquartered in South Korea. The company’s location in South Korea may influence its regulatory compliance processes, particularly if it markets devices globally, though individual devices must meet the specific regulatory requirements of the countries where they are sold.

Wosem Co., Ltd.’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion indicates compliance with EU regulatory requirements for device registration, though it does not imply approval or clearance—only that the devices are documented in the system as required by EU law.

Wosem Co., Ltd.’s devices are classified as Class I under medical device regulations. This classification typically applies to devices posing minimal risk, such as those used for general support or non-invasive therapeutic purposes. Class I devices generally undergo less stringent scrutiny than higher-risk classes but still require compliance with essential safety and performance requirements.