Medical device licence · 89128 · Class 3
COMPONEER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed June 27, 2012. It is in Health Canada’s list of active licences.
- Licence number
- 89128
- Licence holder
- ColteneLangenau, Germany
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 27, 2012
- Devices covered
- 9
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COMPONER SYSTEM - ACCESSORY SET
- COMPONER SYSTEM - BASIC SYSTEM
- COMPONER SYSTEM - ETCHANT GEL S
- COMPONER SYSTEM - ONE COAT BOND
- COMPONER SYSTEM - PREMIUM SYSTEM KIT
- COMPONER SYSTEM - REFILL
- COMPONER SYSTEM - SET
- COMPONER SYSTEM - SET XL
- COMPONER SYSTEM - SYNERGY D6
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.