Medical device licence · 106144 · Class 3
LUNA 2
Yes: licensed in Canada
Licence status Issued (active); first licensed May 17, 2021. It is in Health Canada’s list of active licences.
- Licence number
- 106144
- Licence holder
- SDI LimitedBayswater, VIC, Australia
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 17, 2021
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- LUNA 2 COMPLET
- LUNA 2 SYRINGE
- LUNA 2 SYRINGE SAMPLE
- LUNA 2, 5 SYRINGE INTRODUCTORY KIT
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.