ApprovalTrail

Medical device licence · 88841 · Class 2

PROPLAN CMF GUIDES

Yes: licensed in Canada

Licence status Issued (active); first licensed May 11, 2012. It is in Health Canada’s list of active licences.
Licence number
88841
Licence holder
Materialise N.V.Leuven, Belgium
Risk class
Class II (low to moderate risk)
Licence type
Device Family
First licensed
May 11, 2012
Devices covered
17

Devices on this licence

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

  • PATIENT SPECIFIC GUIDE - CRANIUM, FOREHEAD
  • PATIENT SPECIFIC GUIDE - CRANIUM, FRONTAL BANDEAU
  • PATIENT SPECIFIC GUIDE - CRANIUM, GRAFT
  • PATIENT SPECIFIC GUIDE - DISTRACTOR POSITIONING
  • PATIENT SPECIFIC GUIDE - GRAFT HARVESTING
  • PATIENT SPECIFIC GUIDE - MANDIBLE
  • PATIENT SPECIFIC GUIDE - MIDFACE
  • PATIENT SPECIFIC GUIDE, WITH PLANNING
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - BASIC MANDIBLE RECONSTRUCTION
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - BASIC MIDFACE RECONSTRUCTION
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - CRANIOFACIAL RECONSTRUCTION WITH MODEL
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - CRANIOFACIAL RECONSTRUCTION, WITHOUT MODEL
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - DISTRACTION
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MANDIBLE RECONSTRUCTION
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MANDIBLE RECONSTRUCTION, NO MODEL
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MIDFACE RECON, NO MODEL
  • PATIENT SPECIFIC INSTRUMENT AND PLANNING KIT - MIDFACE RECONSTRUCTION

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