LiDCO Limited Certifications / Registration

In the UK, the Company's design, manufacture and quality management systems are certified as being compliant with the requirements of ISO 9001:2000 and ISO 13485:2003. Manufacture and release of all devices and components is in accordance with the relevant European Directives and with the relevant parts of the US Code of Federal Regulations.

Product Registration Status

LiDCO System

The LiDCOplus Hemodynamic Monitoring System consists of electromedical equipment, sterile medical disposable elements and a sterile injectate.

European Union (EU)  The device components of the LiDCOplus System have been approved for manufacture and marketing in the EU following a satisfactory audit of the Company's quality system in accordance with ISO 9001:2000 and ISO 13485:2003. The device aspects of the LiDCOplus System are CE marked, ias evidence that they meet the essential requirements of the EU Medical Devices Directive.

The lithium chloride injectate (the marker substance used in the LiDCO System) is regarded in the EU as a medicinal product and is subject to approval by the agency responsible for controlling medicines in each Member State. Marketing Authorizations for the lithium chloride injectate have been granted in Austria, Belgium, Czech Republic, Denmark, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden and the U.K.. Marketing Authorisations in other EU Member States will be pursued via the EU Mutual Recognition Procedure.

USA  Following a 510(k) premarket notification to the FDA, the LiDCOplus System (including the lithium chloride injectate) was cleared for marketing in the USA.

Japan  Regulatory approvals in Japan are the responsibility of Nipro Corporation, the Group's distribution partner in Japan. Having completed pre-clinical trials, the LiDCO System is now undergoing clinical trials.