Medical device licence · 104384 · Class 2
PENTACAM AXL WAVE
Yes: licensed in Canada
Licence status Issued (active); first licensed February 28, 2020. It is in Health Canada’s list of active licences.
- Licence number
- 104384
- Licence holder
- Oculus Optikgeraete GmbhWetzlar, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Single Device
- First licensed
- February 28, 2020
- Devices covered
- 1
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PENTACAM AXL WAVE
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “pentacam”. A notice may cover another product or only some lots: read it to see what it covers.
- Pentacam® AXL Wave and Myopia Master®August 24, 2023 · Ophthalmology · Performance · Type II
- Pentacam AxlJuly 25, 2022 · Ophthalmology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.