Medical device licence · 105663 · Class 2
RETCAM ENVISION
Yes: licensed in Canada
Licence status Issued (active); first licensed December 23, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 105663
- Licence holder
- Natus Medical Denmark ApsTaastrup, Denmark
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 23, 2020
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- RETCAM ENVISION 130 DEGREE LENS
- RETCAM ENVISION 80 DEG
- RETCAM ENVISION PORTRAIT LENS
- RETCAM ENVISION SYSTEM WITH FA
- RETCAM ENVISION SYSTEM WITHOUT FA
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.