ApprovalTrail

Medical device licence · 79276 · Class 3

PRELUDE SE

Yes: licensed in Canada

Licence status Issued (active); first licensed March 12, 2009. It is in Health Canada’s list of active licences.
Licence number
79276
Licence holder
Danville MaterialsCarlsbad, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
March 12, 2009
Devices covered
6

Devices on this licence

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

  • PRELUDE ADHESIVE
  • PRELUDE DUAL/SELF-CURE LINK
  • PRELUDE PRIMER
  • PRELUDE PRIMER/ADHESIVE PACK
  • PRELUDE SE KIT
  • PRELUDE TE KIT

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