CellTivity Scientific, Inc.

CellTivity Scientific, Inc. manufactures two primary devices: a Patient Biopsy Kit, which is used for collecting tissue samples, and the Van Gogh Microscopy System. The Van Gogh system is specifically designed for real-time assessment of biopsy adequacy, helping clinicians evaluate biopsy samples during procedures to inform immediate diagnostic decisions.

CellTivity Scientific, Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the provided information.

Yes, CellTivity Scientific, Inc.’s devices are listed in the eudamed database. This registry is used in the European Union to track medical devices that have been authorised for placement on the market, ensuring transparency and traceability for regulatory oversight.

CellTivity Scientific, Inc.’s devices are classified as Class A under EU medical device regulations. This classification is typically assigned to low-risk devices, such as general-purpose surgical instruments or devices with minimal potential harm to patients. Classification determines the regulatory pathway and documentation requirements for market authorisation.