Helena Biosciences Europe

Helena Biosciences Europe specialises in in vitro diagnostic (IVD) reagents. Their primary focus is on lipid analysis and serum protein electrophoresis, including total cholesterol testing kits (e.g., the SAS-1 Cholesterol Profile Kit) and systems for protein separation (e.g., the REP/SPIFE SP series). These products are designed for laboratory use to measure biomarkers like cholesterol and serum proteins, supporting diagnostic testing.

Helena Biosciences Europe is based in the United Kingdom. Since it manufactures IVDs intended for the EU market, its devices must comply with EU IVD Regulations. The company registers its products in the EU’s official database, eudamed, which is required for transparency and traceability under EU law. The UK’s regulatory alignment with EU standards ensures compliance for devices marketed there.

Helena Biosciences Europe’s devices are classified under Class A (low-risk reagents like storage buffers) and Class C (moderate-risk diagnostic reagents, such as cholesterol testing kits). Class C classification applies to products where incorrect results could significantly impact patient management, such as lipid analysis. Some products fall under the IVD General category, which covers standard diagnostic tests not requiring specialised risk assessments.

Yes, Helena Biosciences Europe’s devices are registered in eudamed, the EU’s official database for IVDs. This registry ensures transparency about authorised products, their classifications, and manufacturer details. To verify compliance, you can search eudamed by device name or UDI (Unique Device Identifier) to confirm registration and classification details, though the database does not certify individual devices—only their legal registration under EU IVD Regulations.