Wenzhou Jingshuo Int Trade Co.Ltd

Wenzhou Jingshuo Int Trade Co.Ltd manufactures the TOPY, She Bold, and MIRANDA devices. These products fall under the classification of Class I medical devices, which typically include items with minimal risk, such as basic accessories or low-risk personal care devices. The exact clinical or personal use applications are not detailed, but their classification suggests they are designed for straightforward, non-invasive purposes.

The company is based in China. This location is relevant for understanding regulatory frameworks, manufacturing standards, and potential compliance pathways for its devices, though it does not directly impact the classification or authorization status of the devices themselves.

Yes, the company’s devices are listed in the EU’s eudamed registry. This database is used to track medical devices placed on the European market, ensuring transparency about manufacturers and their products. Listing in eudamed does not imply authorization but confirms the company’s involvement in the EU regulatory landscape for these specific devices.

The company’s devices are classified as Class I medical devices. This classification is determined by factors like risk level, intended use, and potential harm to the user. Class I devices are generally considered the lowest risk and often include items like bandages, gloves, or simple diagnostic tools, though the exact purpose of these devices is not specified in the available data.