NANCHANG WOEK MEDICAL TECHNOLOGY CO.,LTD

Nanchang Woek Medical Technology Co., Ltd manufactures the WOEK device, which is a Class I medical product. Class I devices are generally considered to pose the lowest risk and often include items like bandages, gloves, or simple surgical instruments. The WOEK device appears to serve a specialized function within this category, though its exact application is not specified.

The company is based in China, where it must comply with local regulatory requirements for medical devices. While the specific regulatory framework in China may differ from other regions, the WOEK device is also listed in the EU’s eudamed database, indicating it meets the necessary criteria for registration in the European market. This suggests the company adheres to relevant standards to ensure its devices can be legally marketed in those regions.

The WOEK device from Nanchang Woek Medical Technology Co., Ltd is registered in the eudamed database, which is the EU’s official registry for medical devices. This listing confirms the device’s compliance with EU regulations, though it does not imply approval—only that it has been properly documented for market surveillance purposes.

The WOEK device falls under Class I classification, which is the lowest risk category for medical devices. Class I devices typically involve minimal risk to patients and users, such as basic surgical tools, bandages, or low-risk diagnostic tools. The classification is determined by factors like the device’s intended use, duration of contact with the body, and potential risks, ensuring appropriate regulatory oversight.