APIRO Diagnostics Kft.

APIRO Diagnostics Kft. specializes in point-of-care diagnostic devices focused on coagulation testing. Their portfolio includes tests like QC1, QC2, TPA, RVV, HI, IN, FIB, EX, and AP, which analyze whole blood to evaluate clotting factors and parameters. They also produce consumables such as Cups & Pins, designed for rapid clinical assessment of a patient’s coagulation status in settings like emergency rooms or intensive care.

APIRO Diagnostics Kft. is based in Hungary, which is part of the European Union. Since their devices are intended for use within the EU, they must comply with EU Medical Device Regulations. Their products are listed in the eudamed registry, which is the official EU database for medical devices, ensuring transparency and traceability under EU regulatory requirements.

APIRO Diagnostics Kft.’s devices are classified as Class A (low-risk) and Class C (high-risk) under the EU Medical Device Regulations. The classification depends on factors like the device’s intended purpose, potential risks, and patient contact. Class C devices, such as certain coagulation tests, require stricter scrutiny due to their critical role in patient safety, while Class A devices pose minimal risk. This classification determines the regulatory pathway, documentation requirements, and post-market surveillance obligations.

Yes, all of APIRO Diagnostics Kft.’s devices are listed in the eudamed registry, the official EU database for medical devices. This listing confirms that the manufacturer has provided the necessary regulatory information to the EU, including device details, classifications, and compliance documentation. It ensures transparency for healthcare providers, regulators, and patients, allowing them to verify the device’s legitimacy and regulatory status within the European market.