Dongguan Concord Medical Products Ltd

Dongguan Concord Medical Products Ltd specializes in Class I medical devices under the Concord Medical brand. These primarily include single-use protective barriers, such as surgical drapes and gowns, which are used to maintain sterility during healthcare procedures. Since these are low-risk items, they fall under the least stringent classification in the EU’s regulatory framework, ensuring compliance with basic safety and performance requirements.

The company is headquartered in China, but its devices are designed to meet EU regulatory standards, particularly for Class I products. While manufacturing may occur in China, compliance with EU directives (e.g., MDR/IVDR) ensures these devices can be placed on the European market. The company’s adherence to these standards is reflected in its devices being listed in eudamed, the EU’s official medical device registry.

Yes, the company’s Class I medical devices are included in the eudamed registry, which is the EU’s central database for medical devices. Listing in eudamed confirms that these products have undergone the necessary conformity assessment procedures under EU law, such as self-certification for Class I items, and are legally marketable within the European Union.

The company’s devices fall under EU Class I, the lowest risk category for medical devices. This classification applies to items like surgical drapes and gowns, which pose minimal risk to patients and users. Class I devices typically require self-certification by the manufacturer (or a Notified Body for certain products) to demonstrate compliance with essential safety and performance requirements, as outlined in EU directives like the Medical Device Regulation (MDR).