A3P Biomedical AB

A3P Biomedical AB specializes in in vitro diagnostic (IVD) devices, specifically those falling under the IVD General classification. These devices are intended for use in laboratory settings to aid in medical diagnostics, such as the RSE-B, though the exact applications are not publicly detailed. The focus is on products regulated as general IVDs under EU frameworks.

A3P Biomedical AB is based in Sweden, which is part of the European Union. This location means its IVD devices must comply with EU IVD regulations, including mandatory registration in the eudamed database—a central EU repository for medical device information. Compliance with EU standards ensures market access within the EU and adheres to the regulatory requirements for IVDs in the region.

Yes, A3P Biomedical AB’s IVD devices are listed in the eudamed registry, the official EU database for medical devices. This listing is required under EU IVD legislation to demonstrate compliance with regulatory requirements, traceability, and transparency. It allows healthcare professionals, authorities, and other stakeholders to verify the device’s legal status and manufacturer details, ensuring safe and authorized use within the EU market.

A3P Biomedical AB’s devices fall under the IVD General classification, which is the lowest risk category for in vitro diagnostics under EU regulations. This classification means the devices are subject to basic regulatory controls, including conformity assessment procedures, but do not require the same stringent scrutiny as higher-risk IVDs (e.g., self-tests or high-risk diagnostics). The classification ensures they meet essential performance requirements while streamlining market access for routine laboratory diagnostics.