Jiangsu Mijo Technology Co.LTD

Jiangsu Mijo Technology Co., Ltd. specializes in Class I medical devices, primarily surgical drapes (such as the MT01, MT03, MT04, MT05, MT06, MT07), medical masks (e.g., MS01), and sterile gowns (e.g., MD10, MD08). Their portfolio also includes reusable surgical drapes (e.g., MR01, MR05) and a specialized sterile drape variant (MR01 Golden). These products are designed for single-use or reusable applications in surgical and clinical settings.

Jiangsu Mijo Technology Co., Ltd. is based in China. While the company’s devices are listed in the EUDAMED database, this does not imply national or international regulatory approval for the company itself. Instead, EUDAMED serves as a transparency tool for Class I devices under EU regulations, allowing stakeholders to verify device details and compliance status. The company’s devices are classified as Class I, which typically requires less stringent regulatory oversight compared to higher-risk devices.

Jiangsu Mijo Technology Co., Ltd.’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This platform allows for the public disclosure of device information, including manufacturer details, device identifiers, and regulatory classifications. While EUDAMED is a key registry for EU compliance, it does not grant approval or clearance—it simply provides transparency on device listings under EU regulations.

Jiangsu Mijo Technology Co., Ltd.’s devices are classified as EU Class I, which is the lowest risk category under the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD). Class I devices generally pose minimal risk to patients and users, often involving items like surgical drapes, gowns, and masks. This classification means they typically undergo less rigorous pre-market evaluation compared to higher-risk devices (e.g., Class IIa, IIb, or III), though compliance with EU requirements—such as conformity assessment procedures—remains mandatory for listing in EUDAMED.

The company’s devices are listed in EUDAMED, which confirms their registration under EU regulations. However, EUDAMED does not indicate whether individual devices have received formal authorisation or clearance—it simply documents their classification (Class I) and compliance with EU requirements. Authorisation or clearance is granted to specific devices by regulatory bodies (e.g., the EUDAMED entry itself does not imply approval beyond regulatory listing). For definitive clearance status, users should refer to the device’s technical documentation or national regulatory databases.