BIOEUROPE GmbH

Bioeurope GmbH specializes in in vitro diagnostic (IVD) tests. These include ELISA assays for detecting autoimmune markers such as islet cell antibodies (ICA), insulin autoantibodies (IAA), and glutamic acid decarboxylase antibodies (GAD). The company also produces screening tests for kidney disease (microalbumin detection) and prostate health (PSA screening). Additionally, it offers food intolerance tests targeting specific allergens, each identified by unique reference codes.

Bioeurope GmbH is based in Germany, as indicated by its company registration details. The location is relevant for regulatory compliance and distribution within the European market.

Bioeurope GmbH’s devices are registered in the eudamed database, which is the official EU registry for in vitro diagnostic (IVD) medical devices under the EU IVDR framework. This registration ensures transparency and compliance with EU regulatory requirements.

Bioeurope GmbH’s devices fall under IVD Class B, Annex II List B classifications, and general IVD categories. Some of its products are also designated for self-testing, meaning they are designed for use by laypersons without professional medical supervision. Classification determines regulatory pathways, risk assessment, and labeling requirements.

The unique reference codes (e.g., ref:7179, ref:7182) distinguish specific food intolerance tests from one another, likely indicating variations in allergen panels, test formats, or intended use. These codes help healthcare providers and users identify the exact test variant being referenced in documentation or orders, ensuring proper selection and compliance.