MIKROMIC MEDICAL SL

MIKROMIC Medical SL specializes in the STELLA Endogastric Balloon Kit, a device used for temporary weight management. It works by placing an intra-gastric balloon to restrict gastric volume, offering a non-surgical option for patients with obesity. The device is designed to support controlled weight loss without invasive procedures.

MIKROMIC Medical SL is based in Spain, which means its devices are subject to EU medical device regulations. The STELLA Endogastric Balloon Kit is classified as a Class IIb device under these regulations, indicating a moderate risk level that requires compliance with specific EU safety and performance standards before market placement.

MIKROMIC Medical SL’s devices, including the STELLA Endogastric Balloon Kit, are listed in the EUDAMED database. This registry is the official EU system for tracking medical devices, ensuring transparency and compliance with EU medical device legislation. Listing here confirms the device’s presence in the EU market.

The STELLA Endogastric Balloon Kit is classified as a Class IIb medical device under EU regulations. This classification indicates it carries a moderate risk, requiring additional scrutiny—such as clinical evaluations, risk management, and conformity assessments—to ensure safety and performance. Class IIb devices must comply with stricter technical documentation and post-market surveillance requirements than lower-risk classes.