TLA Targeted Immunotherapies AB

TLA Targeted Immunotherapies AB specializes in devices for targeted immunotherapy. Their current product, TLA GUT, is designed specifically for the treatment of ulcerative colitis (UC), a chronic inflammatory condition of the gastrointestinal tract. This device focuses on localized therapeutic interventions within the gut.

TLA Targeted Immunotherapies AB is headquartered in Sweden. The company’s location is relevant for regulatory compliance, as it operates under the EU’s medical device regulations, which apply to its products.

TLA Targeted Immunotherapies AB’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry is used to track device information, including classification, manufacturers, and regulatory status, ensuring transparency and compliance with EU medical device regulations.

TLA Targeted Immunotherapies AB’s devices fall under EU Device Class IIb. This classification is determined by factors such as the device’s intended use, potential risks, and the level of oversight required for patient safety. Class IIb devices are considered to have a moderate to high risk and require additional scrutiny, including conformity assessment procedures, to ensure their safety and performance.