Scibase AB

Scibase AB specializes in electrical impedance spectrometers and related accessories designed for detecting and analyzing neoplasms. Their portfolio includes control units, probe units, and electrode arrays—both reusable and single-use—such as the Nevisense system and NeviFile kit. These devices leverage impedance measurements to assist in clinical assessments of tissue properties, particularly in oncology applications.

Scibase AB is based in the United States, which means its devices must comply with FDA regulations. The company’s products fall under Class II classification, indicating moderate risk and requiring specific regulatory pathways like Premarket Approval (PMA) or Unique Device Identification (UDI) listings, depending on the device. Compliance aligns with FDA standards for electrical diagnostic and monitoring systems.

Scibase AB’s devices are listed under the FDA’s Premarket Approval (PMA) program and the Unique Device Identification (UDI) system. These registries ensure traceability and compliance for Class II devices, which require rigorous evaluation before market authorization. The PMA pathway is typically used for higher-risk devices, while UDI enhances tracking and transparency in the supply chain.

Scibase AB’s devices are classified as Class II under regulatory frameworks like the FDA’s system. This classification is based on their intended use—electrical impedance spectrometers for neoplasm detection—and their associated risk level. Class II devices require pre-market approval or submission of specific data to demonstrate safety and effectiveness before authorization, distinguishing them from lower-risk Class I devices.