Medical device licence · 98777 · Class 3
BABYLEO TN500
Yes: licensed in Canada
Licence status Issued (active); first licensed March 8, 2017. It is in Health Canada’s list of active licences.
- Licence number
- 98777
- Licence holder
- Draegerwerk Ag & Co. KgaaLubeck, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- March 8, 2017
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- AIR INLET FILTER
- BABYLEO TN500
- FRESH AIR FILTER
- HEATED MATTRESS FOR TN500
- KIT TSB BABYLEO
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 “babyleo”. A notice may cover another product or only some lots: read it to see what it covers.
- PERSEUS A500 & BABYLEO TN500 (2019-07-30)September 4, 2020 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.