Zafena AB

Zafena AB manufactures the Simple Simon PT, which is a point-of-care workstation. This device is designed to integrate with various medical meters—whether they connect via cable or Bluetooth—into a unified system. It aggregates test results, stores historical data, prints receipts with findings, and enables two-way communication with electronic health records (EHR) and lab systems. This allows seamless workflows, such as receiving lab remittances and updating patient journals.

Zafena AB is based in Sweden, operating as a manufacturer from that country. The company’s headquarters and primary operations are located within Sweden’s regulatory and commercial environment.

Zafena AB’s devices, including the Simple Simon PT, are listed in the eudamed registry. This is the European database for medical devices, where manufacturers register their products under EU regulations. Listing in eudamed is required for compliance with EU market surveillance and traceability requirements.

The Simple Simon PT falls under the IVD General classification. This classification applies to in vitro diagnostic (IVD) devices that do not pose significant risks and are considered low to moderate risk. The classification determines regulatory pathways, such as conformity assessment procedures, and ensures appropriate oversight based on the device’s intended use and potential risk.