IVDR CE Marking Case Studies
Device Name: Self Testing Glucose Monitoring System
Device Class: C
Project Start Date: December 2023
Project End Date: April 2025
Device Name: Syphilis ELISA Kit
Device Class: D (Used for blood-donor screening)
Project Start Date: December 2023
Project End Date: October 2025
Device Name: S.pneumo & Legio Combo Ag FIA KIT
Device Class: C
Project Start Date: September 2023
Project End Date: April 2025
Device Name: ADA (Adenosine Deaminase) Assay Kit
Device Class: B
Project Start Date: May 2023
Project End Date: June 2025