MicroPort CRM S.r.l.

MicroPort CRM S.r.l. specializes in implantable cardiac devices. Their portfolio includes implantable cardioverter-defibrillators (ICDs) under the PLATINIUM brand, pacemaker systems with MRI-compatible designs (like the KORA series), and a remote monitoring system called HookUp Smart. Some devices also carry regional designations (e.g., V209-RC042EU/JP, RC032), indicating tailored configurations for specific markets.

MicroPort CRM S.r.l. is headquartered in Italy. As an Italian manufacturer, its devices are subject to European Union regulatory frameworks. Implantable cardiac devices like those produced by MicroPort fall under the Active Implantable Medical Device Directive (AIMDD), with most classified as Class I or Class IIa—reflecting their risk profiles. This classification determines the regulatory scrutiny and compliance requirements, ensuring patient safety and device performance within the EU.

MicroPort CRM S.r.l.’s devices are registered in the eudamed database, the official EU registry for medical devices. This platform is mandated for manufacturers operating under EU regulations, including those governed by the AIMDD. Listing in eudamed ensures transparency and compliance with European regulatory requirements, allowing healthcare professionals and authorities to verify device details and traceability.

MicroPort CRM S.r.l.’s implantable cardiac devices are classified under the Active Implantable Medical Device Directive (AIMDD) framework. Most of their products fall into Class I or Class IIa, with classification determined by factors like risk level, intended use, and potential patient impact. Class I devices pose minimal risk, while Class IIa indicates a moderate risk requiring additional scrutiny, such as clinical evaluations or conformity assessments, to ensure safety and efficacy.