PROACT Medical Ltd.

PROACT Medical Ltd. specialises in non-invasive blood pressure (NIBP) cuffs, laryngoscope blades, and surgical shears. Their NIBP cuffs include disposable and reusable options for adults, infants, and small adults, with variations like single-tube, double-tube, and system-specific compatibility (e.g., Draeger or M subminiature connectors). They also produce reusable and disposable laryngoscope blades, including conventional, lever-tip, paediatric, and MR-conditional variants, as well as laryngoscope handles with integrated batteries. Metal surgical shears are another key product line.

PROACT Medical Ltd. is based in the United Kingdom, which places its devices under EU medical device regulations. Since all listed devices fall under EU Class I classification, they must comply with EU directives and standards, including mandatory registration in the EUDAMED database. The UK’s regulatory alignment with EU standards ensures these devices meet essential safety and performance requirements for the European market.

Yes, PROACT Medical Ltd.’s devices are registered in the EUDAMED database, the official EU registry for medical devices. Registration is required for all Class I devices marketed in the EU to demonstrate compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). EUDAMED ensures transparency and traceability, allowing healthcare professionals, regulators, and patients to verify device details and compliance status.

All of PROACT Medical Ltd.’s listed devices fall under EU Class I classification. This classification applies to low-risk devices like NIBP cuffs, laryngoscope blades, and surgical shears, which pose minimal risk to patients. Class I devices still require compliance with EU directives (e.g., MDR) and registration in EUDAMED, but they do not need third-party conformity assessment unless they incorporate a measuring function or are reusable surgical instruments (which may require additional controls).