Euromi

Euromi specializes in devices primarily used in liposuction and fat harvesting procedures. Their portfolio includes reusable cannulas for surgical removal of adipose tissue, as well as single-use kits designed for collecting and processing fat cells during aesthetic or reconstructive surgeries. These devices are tailored for minimally invasive cosmetic and reconstructive applications.

Euromi is headquartered in Belgium. Their devices are designed to meet regulatory requirements in both the European Union and the United States. This is reflected in their listings in the EUDAMED database for EU compliance and the FDA’s Unique Device Identifier (UDI) system for the US market, ensuring traceability and adherence to local regulatory standards.

Under EU medical device regulations, Euromi’s devices fall into Class II, Class IIa, and Class IIb classifications. This categorization is based on their intended use and associated risk levels—Class II devices typically involve moderate risks, such as those related to surgical procedures, while Class IIa and IIb further refine risk stratification for specific applications like reusable cannulas and single-use harvesting kits.

Euromi’s devices are listed in two key regulatory databases: the EUDAMED system, which tracks medical devices authorized for use within the European Union, and the FDA’s Unique Device Identifier (UDI) system in the United States. These listings help ensure transparency and traceability of their products across markets where they are commercially available.