Medical device licence · 84390 · Class 2
HYFLEX CM FILES
Yes: licensed in Canada
Licence status Issued (active); first licensed November 5, 2010. It is in Health Canada’s list of active licences.
- Licence number
- 84390
- Licence holder
- ColteneLangenau, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- November 5, 2010
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- HYFLEX CM FILE
- HYFLEX CM FILE ASST.
- HYFLEX CM FILE INTRO KIT
- HYFLEX CM SEQUENCE FILE PACK
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.