Medical device licence · 114512 · Class 3
BABYLEO TN500
Yes: licensed in Canada
Licence status Issued (active); first licensed December 16, 2025. It is in Health Canada’s list of active licences.
- Licence number
- 114512
- Licence holder
- Draegerwerk Ag & Co. KgaaLubeck, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 16, 2025
- Devices covered
- 3
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- BABYLEO TN500
- FRESH AIR FILTER
- HEATED MATTRESS FOR TN500
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.