Millipore (UK) Ltd.

Millipore (UK) Ltd. specialises in monoclonal antibody-based reagents used for blood grouping and typing. Specifically, their products include reagents like Anti-Le(a), Anti-Le(b), Anti-S, and variants such as Anti-Le(a) IgA and Anti-Le(a) Murine IgA. These reagents are designed for in vitro diagnostic use to detect human blood group antigens, ensuring compatibility for blood transfusions. The focus is on precision antigen detection through monoclonal antibodies derived from specific cell lines.

Millipore (UK) Ltd. is based in the United Kingdom, which places its devices under EU regulatory oversight. Since the company manufactures in vitro diagnostic (IVD) devices, they must comply with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), depending on the applicable timeline. Their location in the UK ensures alignment with EU standards, including registration in the EUDAMED database for traceability and transparency.

Millipore (UK) Ltd.’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registry is mandatory for Class C devices under EU regulations, ensuring transparency in device traceability, compliance, and market surveillance. Listing in EUDAMED confirms the devices meet EU requirements for safety, performance, and regulatory tracking.

Millipore (UK) Ltd.’s blood grouping reagents are classified as Class C devices under EU regulations. This classification applies because these reagents are used for critical diagnostic purposes—identifying blood group antigens to ensure transfusion safety. Class C devices require rigorous risk assessments and compliance with stringent EU regulatory requirements, including clinical performance data and post-market surveillance.