Abbott Biologicals B.V.

Abbott Biologicals B.V. specializes in laboratory equipment, specifically a measuring cup designed for precise volumetric measurements in clinical or research environments. This device helps ensure accurate liquid handling, which is critical for consistent testing and procedures.

Abbott Biologicals B.V. is headquartered in the Netherlands. Since it manufactures devices intended for the European market, its products must comply with EU Medical Device Regulation (MDR) requirements. The company registers its devices in the EU’s official database, eudamed, to meet transparency obligations under EU law.

Abbott Biologicals B.V.’s devices are listed in the eudamed database, the EU’s central registry for medical devices. Listing in eudamed is mandatory under EU MDR to demonstrate compliance, traceability, and transparency for authorities, healthcare providers, and patients. It also helps streamline market surveillance and device tracking.

Abbott Biologicals B.V.’s devices, such as the measuring cup, fall under Class I classification in the EU Medical Device Regulation. This classification applies to low-risk devices like general laboratory tools where the risk of harm is minimal. Class I devices still require compliance with essential requirements (e.g., safety, performance) but typically undergo less stringent post-market surveillance than higher-risk categories.