International

Certificates and MDR Documents

EU MDR Documents and FreedomEDGE® MDR Labels

QMS Certificate, Declaration of Conformity and FreedomEDGE® labels – for EU. Download as needed.

ISO 13485 Certificate – FM 702589

MDSAP Certificate – MDSAP 695725

EU Quality Management System Certificate (3 pages).
EU MDR Declaration of Conformity (3 pages).
FreedomEdge® Box Label – 314017vB.

FreedomEdge® Box Label – 347034vC. 

FreedomEdge® Symbol Box Label – 348407vA.

Freedom60® Box Label – 334847vC.

What's New for International

  • FLEX Training
  • Freedom® Infusion System SKUs.
  • HCP Guides EU
  • EU MDR

Marketing Materials

  • KORU Needles Brochure (French) was updated Sept 2024.
  • KORU OUS CIPD Leave Behind was updated Sept 2024.
  • Onboarding Flyer
  • Socail Media Content
  • Koru Complete Brochure
  • Freedom60® with PFS Adapter Sell Sheet
  • Freedom60® with PFS Memo
If you encounter any problem, don’t hesitate to contact us. We’ll respond as soon as we can.

At KORU, our Mission is to Empower Patients with the Freedom to Truly Live.