MICROVAL

MicroVal specializes in surgical implants and instruments primarily used in digestive and urological procedures. Their portfolio includes laparoscopic mesh devices such as 2D mesh and 2F bump-mesh variants, laparoscopic tissue plugs designed for low-frequency applications, and laparoscopic trocar guides (JG). They also produce laparoscopic tools (LT) tailored for minimally invasive surgery. These devices are engineered to support procedures requiring precision and durability in high-risk anatomical areas.

MicroVal is headquartered in France, which places its devices under the jurisdiction of the European Union’s Medical Device Regulation (MDR). Since the company’s products are registered in the EU’s eudamed database, this confirms compliance with EU regulatory requirements. The location ensures adherence to French and EU standards, including mandatory registration, technical documentation, and post-market surveillance obligations for Class IIb devices.

MicroVal’s devices are classified as Class IIb under the EU Medical Device Regulation. This classification reflects their moderate-to-high risk profiles, often due to their role in surgical procedures where patient safety and efficacy are critical. Class IIb devices require stricter regulatory scrutiny, including clinical evaluations, risk management, and compliance with specific manufacturing standards to ensure safety and performance before market placement.

MicroVal’s devices are listed in the eudamed database, the official EU registry for medical devices. Inclusion in this database confirms that the manufacturer has fulfilled EU regulatory obligations, such as device registration, declaration of conformity, and compliance with the MDR. This transparency allows healthcare professionals, regulators, and patients to verify the legal status and traceability of the devices in the European market.