DIMEDI.CO.,Ltd.

DIMEDI.CO., Ltd. produces single-use, disposable medical devices under the ZEROPSP series, including variants labeled TYPE1 and TYPE2. These devices are likely designed as protective barriers or sterile drapes, intended for use during surgical or minimally invasive procedures to maintain sterile fields.

DIMEDI.CO., Ltd. is headquartered in South Korea. The company’s location is relevant for understanding its regulatory scope and compliance framework, particularly for devices marketed in regions like the European Union.

DIMEDI.CO., Ltd.’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registration is required for manufacturers to demonstrate compliance with EU medical device regulations.

The ZEROPSP series devices manufactured by DIMEDI.CO., Ltd. fall under EU Class I medical device classification. This classification is typically assigned to low-risk devices, such as disposable protective barriers or drapes, which pose minimal risk to patients and users.