DAEYOMEDI Co., Ltd.

DAEYOMEDI Co., Ltd. manufactures medical devices under the brand name DAEYOMEDI, focusing on products classified under Class IIa. These devices are typically used for diagnostic, monitoring, or therapeutic purposes, though the exact functions or specific product names are not detailed in the provided information.

DAEYOMEDI Co., Ltd. is headquartered in South Korea. The company operates within the regulatory framework of its country of origin while ensuring compliance with relevant standards for medical devices.

Yes, DAEYOMEDI Co., Ltd.’s devices are listed in the eudamed registry, which is the European database for medical devices. This listing is relevant for transparency and regulatory tracking within the EU market.

DAEYOMEDI Co., Ltd.’s devices fall under Class IIa classification, which is a moderate-risk category in the medical device regulatory framework. This classification requires compliance with specific safety, performance, and documentation standards to ensure their proper use and risk management.

The Class IIa classification determines the regulatory requirements DAEYOMEDI Co., Ltd. must meet, including technical documentation, clinical evaluations, and post-market surveillance. This classification balances risk assessment with necessary oversight to ensure patient safety and device efficacy.