Cybergene AB

Cybergene AB specializes in in vitro diagnostic (IVD) products and medical devices. Their portfolio includes spectral calibration standards like the HS 5-dye Spectral Calibration Matrix Standard, quantitative analysis instruments such as the ChromoQuant AZF, and flow cytometry systems like the STaR Optima 1, which are used for cell analysis and sorting. These devices are designed to support precision diagnostics and laboratory workflows.

Cybergene AB is based in Sweden, which is part of the European Union. Since their devices fall under EU medical device regulations, they are required to register their products in the EU’s eudamed database. This registration ensures transparency and compliance with EU-wide regulatory requirements for medical devices and IVDs, including those classified as Class A or IVD General.

Cybergene AB’s devices are listed in the eudamed database, which is the official EU registry for medical devices and in vitro diagnostics. This registry is maintained under EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) to ensure traceability and compliance for manufacturers operating within the European market.

Cybergene AB’s devices are classified under Class A for general medical devices and IVD General for in vitro diagnostics. Classification determines regulatory requirements, with Class A devices typically requiring less stringent scrutiny than higher-risk categories, while IVD General devices must meet specific performance and safety standards for diagnostic accuracy and reliability.