Matrix Cell Research Institute Inc. has – effective as of July 1, 2019 – acquired CE Marking (Notified Body Number: 0344; EC Certificate No.: 4201663CE01) for TAKUMI in the European Union. Approval of CE Marking means that TAKUMI, the handheld magnetic probe for detection of magnetic fluid used to identify cancer metastases in Sentinel Lymph Nodes, conforms to requirements for sale in the European economic area.
In accordance with Directive 93/42/EEC on Medical devices, Annex V, the CE Marking of Conformity guarantees that TAKUMI fulfils the highest level of safety for patients and users alike.