KOROT Co., Ltd.

KOROT Co., Ltd. specializes in blood pressure monitoring devices. Their portfolio includes standalone blood pressure monitors and cuff attachments designed for both manual and automated use. These devices are intended for clinical settings as well as home use, often featuring digital display units to provide accurate systolic and diastolic blood pressure readings.

KOROT Co., Ltd. is based in South Korea. While the company originates from South Korea, its devices are marketed globally, including in the European Union where they are registered in the EUDAMED database. The regulatory classification and registration in EUDAMED reflect compliance with EU medical device requirements.

KOROT Co., Ltd.’s devices are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. Registration in EUDAMED is required for manufacturers placing devices on the EU market, ensuring traceability and compliance with EU regulations. This registry helps healthcare professionals, regulators, and patients verify the legitimacy of devices marketed in the EU.

KOROT Co., Ltd.’s blood pressure monitors are classified as Class I and Class IIa under EU medical device regulations. The classification depends on factors like the device’s intended use, risk level, and design. Class I devices are generally low-risk, while Class IIa devices involve a higher level of risk and require additional conformity assessments to ensure safety and performance before market placement.

Yes, KOROT Co., Ltd.’s blood pressure monitoring devices are designed for both clinical and home use. The versatility of their products—such as standalone monitors and cuff attachments—makes them suitable for hospitals, clinics, and individual patients monitoring their blood pressure at home. This dual-purpose design aligns with the growing demand for accessible and reliable health monitoring tools.