OXUS Co., Ltd.

OXUS Co., Ltd. specializes in medical imaging devices, specifically ultrasound systems like the RAK-U06M2E and RAK-U03M2E. These devices are designed for diagnostic imaging, allowing healthcare professionals to visualize internal body structures for medical evaluation.

OXUS Co., Ltd. is headquartered in South Korea. The company’s location is relevant for understanding its regulatory context, as medical device regulations can vary by country.

OXUS Co., Ltd.’s devices, such as the RAK-U06M2E and RAK-U03M2E, fall under Class IIb classification in the EU. This classification applies to devices that pose a moderate risk to patients and require additional scrutiny to ensure safety and performance, such as ultrasound systems used for diagnostic purposes.

Yes, OXUS Co., Ltd.’s devices are registered in EUDAMED, the European Union’s medical device registry. This database tracks devices that have undergone the necessary conformity assessment procedures to comply with EU regulations, ensuring transparency and traceability for healthcare professionals and regulators.