Medical device licence · 87618 · Class 2
ONDAMED
No longer licensed: suspended: invalid quality-system certificate
Licence status Suspended: invalid quality-system certificate; first licensed November 14, 2011; ended December 11, 2019. It is in Health Canada’s archive of licences no longer in force.
- Licence number
- 87618
- Licence holder
- Ondamed GmbhSchwanau, 08, Germany
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- November 14, 2011
- Ended
- December 11, 2019
- Devices covered
- 6
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ONDAMED - FLEX APPLICATOR
- ONDAMED - HAND APPLICATOR
- ONDAMED - MASTER UNIT
- ONDAMED - MATRIX APPLICATOR
- ONDAMED - NECK APPLICATOR
- ONDAMED - REGULATOR
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.