Medical device licence · 91718 · Class 2
SYNFLATE SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed July 22, 2013. It is in Health Canada’s list of active licences.
- Licence number
- 91718
- Licence holder
- Synthes GmbhOberdorf, Switzerland
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- July 22, 2013
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACCESS DRILL
- ACCESS KIT
- BIOPSY KIT
- SYNFLATE BALLOON
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.