CENEFOM CORP.

Cenefom Corp. specializes in surgical medical devices, including tissue interface patches (like the STIP), haemostatic agents (such as HIMOSTA), wound care dressings (e.g., Anscare), and bipolar radiofrequency ablation systems (e.g., BTX Surg). These devices are primarily designed for minimally invasive procedures, wound management, and tissue sealing applications.

Cenefom Corp. is based in Taiwan. Its devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This registration is required for devices intended to be distributed within the European market under the Medical Device Regulation framework.

All devices produced by Cenefom Corp. fall under EU Class I classification. This classification is determined based on the risk associated with the device’s intended use and design, with Class I representing the lowest risk category in the EU’s medical device hierarchy.

The provided information only confirms that Cenefom Corp.’s devices are registered in EUDAMED and classified under EU Class I, indicating compliance with the Medical Device Regulation (MDR) for distribution within the European Union. Whether these devices are also authorised or marketed in other regions (e.g., the US, Asia, or globally) is not specified in the available data.