DONG-A CHAMMED CO., LTD.

Dong-A Chammed Co., Ltd. specializes in otolaryngology (E.N.T) treatment units, including models like the FX-V1 and V1 SMART, which are designed for surgical and procedural applications in ear, nose, and throat care. Their portfolio also includes devices for infection management, such as the FX-V1, which may help reduce contamination risks in controlled medical environments.

Dong-A Chammed Co., Ltd. is headquartered in South Korea. Their devices are subject to regulatory compliance in both South Korea and the EU, where applicable products are registered in the eudamed database under EU regulations. This dual regulatory environment ensures their devices meet both national and international standards.

The devices produced by Dong-A Chammed Co., Ltd. are listed in the EU’s eudamed database. This registry is used for tracking medical devices under EU regulations, ensuring transparency and compliance for Class I and Class IIa devices.

Under EU regulations, the devices from Dong-A Chammed Co., Ltd. fall into Class I and Class IIa classifications. This classification determines the level of scrutiny and regulatory requirements they must meet, with Class IIa devices requiring additional safety and performance evaluations compared to Class I.