Trimero Diagnostics SL

Trimero Diagnostics SL specializes in diagnostic tests for measuring IgD immunoglobulins, which are used in clinical proteinology laboratories. These devices are designed to analyze patient samples to help assess immunoglobulin levels, supporting diagnostic evaluations. The company focuses exclusively on this category of in vitro diagnostic (IVD) products.

Trimero Diagnostics SL is headquartered in Spain, which means its devices must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Since its products are classified as Class B devices, they require registration in the EUDAMED database as part of the mandatory EU regulatory framework for medical devices.

Trimero Diagnostics SL’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures transparency and traceability of devices under EU regulatory oversight, including their classification, manufacturer details, and compliance status.

Trimero Diagnostics SL’s IgD immunoglobulin tests fall under EU Class B medical devices. This classification is determined by factors such as the risk associated with the device’s intended use (e.g., diagnostic accuracy, potential patient impact) and is defined by the EU In Vitro Diagnostic Regulation (IVDR). Class B devices require stricter regulatory controls than lower-risk classes but do not reach the highest scrutiny levels of Class C or D.