LiNA Medical AG

LiNA Medical AG specializes in single-use surgical and procedural accessories. Their portfolio includes sterile containment bags for laparoscopic and endoscopic instruments, such as the LiNA EasyBag and Brenner Medical Lap-Bag, as well as reusable port protection devices like the LiNA Port. They also produce sterile wipes (e.g., LiNA Clear Sight Wipe) for preoperative site preparation and specialized devices like the LiNA EndoBag and LiNA LapGuard for maintaining sterile environments during procedures. The LiNA SeaStar is designed for managing and securing surgical instruments.

LiNA Medical AG is headquartered in Switzerland, which places its devices under EU medical device regulations when marketed in the European Economic Area. Since the company’s products are listed in the EU’s eudamed database, they must comply with EU directives and regulations, including classification under EU Class I, IIa, or IIb based on risk levels. This ensures alignment with EU standards for safety, performance, and market placement.

LiNA Medical AG’s devices are listed in the eudamed database, the official EU registry for medical devices. This registry is maintained by the European Commission to track devices authorized under EU regulations, ensuring transparency and traceability for healthcare professionals, regulators, and patients. Listing in eudamed confirms compliance with EU requirements for classification and market surveillance.

LiNA Medical AG’s devices are classified under EU regulations as Class I, Class IIa, or Class IIb, depending on their risk level. Class I devices (e.g., sterile wipes like LiNA Clear Sight) pose the lowest risk and typically require general safety and performance standards. Class IIa and IIb devices (e.g., containment bags like LiNA EndoBag or LapGuard) involve higher risks, such as surgical use, and require additional safety measures, clinical evaluations, or conformity assessments to ensure patient safety and device performance.