Medical device licence · 103195 · Class 3
ENA BOND
Yes: licensed in Canada
Licence status Issued (active); first licensed July 15, 2019. It is in Health Canada’s list of active licences.
- Licence number
- 103195
- Licence holder
- Micerium S.P.A.Avegno, GE, Italy
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- July 15, 2019
- Devices covered
- 12
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ENA-BOND BOND RESIN
- ENA-BOND CATALYST
- ENA-BOND ENA-ETCH ETCHING GEL 37%
- ENA-BOND SE BONDING KIT
- ENA-BOND SE KIT
- ENA-BOND SE KIT BONDING+PRIMER
- ENA-BOND SE LIGHT CURING BOND RESIN
- ENA-BOND SE PRIMER
- ENA-BOND SEAL SEALER BONDING AGENT
- ENA-BOND TOTAL ETCH BONDING
- ENA-BOND TWO COMPONENT BONDING SYSTEM
- ENT-BOND LIGHT CURING ONE COMPONENT BONDING SYSTEM
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.