Milenia Biotec GmbH

Milenia Biotec GmbH specializes in in vitro diagnostic (IVD) test systems, specifically lateral flow immunoassays. These include rapid qualitative or semi-quantitative assays for detecting biomarkers like human anti-mouse antibodies (HAMA) and interleukin-6 (IL-6). The company also produces control products for assessing hemolysis, icterus, and turbidity (HIT) interference in coagulation diagnostics. These devices are designed for clinical and research use.

Milenia Biotec GmbH is headquartered in Germany, which places its devices under the jurisdiction of the European Union’s In Vitro Diagnostic Regulation (IVDR). Since the company manufactures IVDs classified as Class B (general IVD risk), its products must comply with EU regulatory requirements for market placement. This includes registration in the EUDAMED database, which is the official EU database for medical devices and IVDs.

Milenia Biotec GmbH’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices and in vitro diagnostics. This registry ensures transparency and compliance with the IVDR, allowing healthcare professionals, regulators, and other stakeholders to verify the registration status of its IVD products.

Milenia Biotec GmbH’s devices fall under the IVD General category, specifically classified as Class B under the EU’s In Vitro Diagnostic Regulation (IVDR). This classification is based on the risk associated with the device’s intended use, such as detecting biomarkers or evaluating sample interferences. Class B devices are considered to pose a general risk and require compliance with EU regulatory requirements, including conformity assessment procedures and registration.