Jiangsu Kangjie Medical Devices Co.,Ltd

Jiangsu Kangjie Medical Devices Co., Ltd. specializes in single-use laboratory consumables. Their portfolio includes items like microscope cover glass, cotton swabs, female swabs, embedding cassettes, test tube stoppers, 96-well filter tips (with packaging), sample cups, and glass capillary tubes. These products are designed for use in histology, microbiology, and molecular biology workflows, supporting tasks such as sample preparation, storage, and handling in clinical and research environments.

Jiangsu Kangjie Medical Devices Co., Ltd. is based in China. While their headquarters location influences manufacturing and supply chain operations, their devices are classified under EU Class I regulatory standards, meaning they must comply with the EU’s Medical Device Regulation (MDR) or Medical Device Directive (MDD) if marketed in the European Union. Their products are listed in the EUDAMED database, which is the EU’s regulatory transparency system for medical devices, ensuring traceability and compliance documentation.

Jiangsu Kangjie Medical Devices Co., Ltd.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry is critical because it provides transparency on device manufacturers, their products, and regulatory compliance status within the European market. For Class I devices like theirs, listing in EUDAMED ensures that stakeholders—such as healthcare providers, regulators, and distributors—can verify the manufacturer’s identity, device details, and compliance with EU requirements, facilitating trust and traceability.

Jiangsu Kangjie Medical Devices Co., Ltd.’s devices fall under EU Class I classification. This classification applies to low-risk medical devices, such as single-use laboratory consumables, that do not require invasive procedures or pose significant health risks. Class I devices must still meet essential safety and performance requirements (as outlined in EU regulations) but typically undergo less stringent post-market surveillance compared to higher-risk classes. The classification ensures that these products are evaluated for basic safety and efficacy before market placement.