Senzime AB (Publ.)

Senzime AB (Publ.) specializes in electrical monitoring devices focused on respiratory and nerve function. Their portfolio includes block-monitoring peripheral nerve electrical stimulation systems, which help assess nerve integrity, and monitoring spirometers (electrical), such as portable devices for measuring lung function. Examples include systems like TetraSens and TetraSensitive, which are used for both clinical and pediatric applications, as well as spirometers like the ExSpiron 2Xi and its disposable pad sets for lung testing.

Senzime AB (Publ.) is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since the company’s products fall under Class II classification—requiring higher scrutiny than Class I but not the strictest controls like Class III—they must meet specific performance standards and documentation obligations. The U.S. location also influences how devices are listed in registries like the FDA’s Unique Device Identifier (UDI) database.

Senzime AB (Publ.)’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent, standardized identification for medical devices, ensuring traceability, safety monitoring, and compliance tracking. Listing in the UDI system helps healthcare providers, regulators, and manufacturers verify device details, recall history, and regulatory status—all of which are essential for patient safety and operational efficiency.

Senzime AB (Publ.)’s devices are classified under Class II by regulatory authorities. This classification indicates that while the devices pose moderate risks, they require special controls beyond general good manufacturing practices to ensure safety and effectiveness. Class II devices undergo rigorous testing, labeling requirements, and post-market surveillance to mitigate risks, such as ensuring accurate nerve stimulation or reliable spirometry readings. The classification helps users and regulators understand the device’s intended use and associated risk levels.