Medical device licence · 105919 · Class 2
PROPLAN CMF ORTHOGNATHIC SPLINTS
Yes: licensed in Canada
Licence status Issued (active); first licensed March 9, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 105919
- Licence holder
- Materialise N.V.Leuven, Belgium
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 9, 2021
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PATIENT SPECIFIC GUIDE - ORTHOGNATHIC, FINAL
- PATIENT SPECIFIC GUIDE - ORTHOGNATHIC, INTERMEDIATE
- PATIENT SPECIFIC SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, ONE SPLINT
- PATIENT SPECIFIC SPLINT AND PLANNING KIT, ORTHOGNATHIC KIT, TWO SPLINTS
- PATIENT SPECIFIC SPLINT, PALATAL
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.