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.