Medical device licence · 111887 · Class 3
CORE BUILD-UP
Yes: licensed in Canada
Licence status Issued (active); first licensed September 26, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111887
- Licence holder
- Peter Brasseler Holdings, LlcSavannah, GA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- Device Group Family
- First licensed
- September 26, 2024
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CORE BUILDUP ENAMEL CARTRIDGE
- CORE BUILDUP ENAMEL SYRINGE
- CORE BUILDUP WHITE CARTRIDGE
- CORE BUILDUP WHITE SYRINGE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.