Medical device licence · 80778 · Class 2
PLANMECA ROMEXIS
Yes: licensed in Canada
Licence status Issued (active); first licensed October 1, 2009. It is in Health Canada’s list of active licences.
- Licence number
- 80778
- Licence holder
- Planmeca OyHelsinki, Finland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- October 1, 2009
- Devices covered
- 15
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ROMEXIS 2D IMPLANT MODULE
- ROMEXIS 2D STANDARD
- ROMEXIS 3D ADVANCED
- ROMEXIS 3D CEPHALOMETRY
- ROMEXIS 3D DICOM FULL
- ROMEXIS 3D IMPLANT
- ROMEXIS 3D IMPLANT GUIDE
- ROMEXIS 3D STANDARD
- ROMEXIS CLINIC MANAGEMENT MODULE
- ROMEXIS CMF SURGERY
- ROMEXIS DENTAL PACS
- ROMEXIS DENTAL PACS Q/R SCP WORKSTATION
- ROMEXIS DICOM PRINT
- ROMEXIS RADIOLOGY FINDINGS MODULE
- ROMEXIS SMILE DESIGN
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.