ApprovalTrail

Medical device licence · 97963 · Class 4

ELUNA 8

No longer licensed: discontinued at renewal

Licence status Discontinued at renewal; first licensed November 4, 2016; ended October 29, 2020. It is in Health Canada’s archive of licences no longer in force.
Licence number
97963
Licence holder
Biotronik Se & Co. KgBerlin, 11, Germany
Risk class
Class IV (highest risk)
Licence type
Device Family
First licensed
November 4, 2016
Ended
October 29, 2020
Devices covered
2

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • ELUNA 8 DR-T (PROMRI)
  • ELUNA 8 SR-T (PROMRI)

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.