Certifications

MRI compatibility and safety

Results in the MR enviroment and the posibility of using the device under certain conditions.

Manufacturer's Declaration

In relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 as regards to provisions for certain medical devices

EC Declaration of Conformity

Declaration of conformity is issued under the exclusive responsibility of the manufacturer.

EU Quality Management System

Certification for the quality system of Jeil Medical Corporation.

EU Declaration of Conformity

Declaration of conformity issued under the sole responsability of the manufacturer.