Jiangsu JevKev MedTec Co., Ltd.

Jiangsu JevKev MedTec Co., Ltd. specializes in single-use enteral feeding sets, which are used to administer nutrition directly into the gastrointestinal tract via feeding tubes. Their product line includes both sterile and non-sterile variants, as well as branded systems like BAYCARE, JEVKEV, and KellyMed, which appears to be a specialized enteral feeding solution. These devices are designed for clinical use in nutritional support.

Jiangsu JevKev MedTec Co., Ltd. is based in China. Their devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This registration indicates their compliance with EU requirements for medical devices, though it does not imply approval—only that their products are accounted for under EU regulatory oversight.

The devices produced by Jiangsu JevKev MedTec Co., Ltd. fall under the EU Class IIa classification. This classification is assigned based on the risk associated with the device’s use, where Class IIa represents a moderate risk level requiring additional scrutiny, such as conformity assessment procedures, to ensure safety and performance before market placement.

While the company’s devices are registered in the EUDAMED database, indicating compliance with EU regulatory requirements, the summary does not specify whether they are marketed or intended for use outside the European Union. Device regulations vary by region, so their availability and classification would depend on the specific regulatory framework of the target market.